LBEL PARIS RENOVANCE JOUR- octinoxate, octocrylene, and oxybenzone cream Ventura International LTD Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- L'BEL RENOVÂNCE JOUR Drug Facts Active Ingredients Octinoxate (7.5 %), Octocrylene (5 %), Oxybenzone (3 %) Purpose Sunscreen Uses Helps prevent sunburn Higher SPF gives more sunburn protection Provides moderate protection against sunburn Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Apply smoothly every morning before sun exposure and as needed. Children under 6 months of age: ask a doctor. Other information Moderate sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun. Inactive ingredients Aqua (water), cyclohexasiloxane, soy protein phthalate, glycerin, pisum sativum (pea) extract, c12-15 alkyl benzoate, caprylic / capric triglyceride, cyclopentasiloxane, cetyl alcohol, cetearyl alcohol, isopropyl myristate, isononyl isononanoate, sorbitan stearate, mannitol, glyceryl stearate, potassium cetyl phosphate, dimethicone / vinyl dimethicone crosspolymer, dimethicone crosspolymer, triethanolamine, acrylates / c10-30 alkyl acrylate crosspolymer, ceteareth-20, propylparaben, panthenol, sodium pca, steareth-20, ceteth-20, parfum (fragance), ci 77891 (titanium dioxide), chlorphenesin, dimethiconol, teprenone, ppg-26-buteth-26, polysorbate 80, peg-40 hydrogenated castor oil, tetrasodium edta, cyclodextrin, butylene glycol, hydrolyzed algin, hedera helix (ivy) leaf / stem extract, faex extract (yeast extract), magnesium pca, chlorella vulgaris extract, maris aqua (sea water), algin, tocopheryl acetate, zinc pca, retinyl palmitate, saccharomyces / magnesium ferment, ascorbyl palmitate, serine, urea, acacia, senegal gum, bioflavonoids, allantoin, disodium succinate, saccharomyces /iron ferment, manganese pca, saccharomyces /copper ferment, saccharomyces /calcium ferment, saccharomyces /silicon ferment, saccharomyces /zinc ferment. US: Distributed by Ventura International Ltd. San Francisco, CA 94111 PRINCIPAL DISPLAY PANEL - 50 g Jar Carton L'BEL RENOVÂNCE JOUR intensive refining, fortifying and renewing treatment spf 15 daytime face and neck cream 50 g e (1.7 oz.) LBEL PARIS RENOVANCE JOUR octinoxate, octocrylene, and oxybenzone cream Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:1478 3-0 38 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength O ctino xa te (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51) Octino xate 3.75 g in 50 g O cto crylene (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6 WM) Octo crylene 2.5 g in 50 g O xybenzo ne (UNII: 9 5OOS7VE0 Y) (Oxybenzo ne - UNII:9 5OOS7VE0 Y) Oxybenzo ne 1.5 g in 50 g Inactive Ingredients Ingredient Name Strength wa ter (UNII: 0 59 QF0 KO0 R) cyclo methico ne 6 (UNII: XHK3U310 BA) g lycerin (UNII: PDC6 A3C0 OX) sno w pea (UNII: 8 4SKC33B1I) c12 -15 a lkyl benzo a te (UNII: A9 EJ3J6 1HQ) medium-cha in trig lycerides (UNII: C9 H2L21V7U) cyclo methico ne 5 (UNII: 0 THT5PCI0 R) cetyl a lco ho l (UNII: 9 36 JST6 JCN) ceto stea ryl a lco ho l (UNII: 2DMT128 M1S) iso pro pyl myrista te (UNII: 0 RE8 K4LNJS) iso no nyl iso no na no a te (UNII: S4V5BS6 GCX) so rbita n mo no stea ra te (UNII: NVZ4I0 H58 X) ma nnito l (UNII: 3OWL53L36 A) g lyceryl mo no stea ra te (UNII: 230 OU9 XXE4) po ta ssium cetyl pho spha te (UNII: 0 3KCY6 P7UT) tro la mine (UNII: 9 O3K9 3S3TK) po lyo xyl 2 0 ceto stea ryl ether (UNII: YRC528 SWUY) pro pylpa ra ben (UNII: Z8 IX2SC1OH) pa ntheno l (UNII: WV9 CM0 O6 7Z) so dium pyrro lido ne ca rbo xyla te (UNII: 46 9 OTG57A2) stea reth-2 0 (UNII: L0 Q8 IK9 E0 8 ) ceteth-2 0 (UNII: I8 35H2IHHX) chlo rphenesin (UNII: I6 70 DAL4SZ) tita nium dio xide (UNII: 15FIX9 V2JP) tepreno ne (UNII: S8 S8 451A4O) po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H) po lyo xyl 4 0 hydro g ena ted ca sto r o il (UNII: 7YC6 8 6 GQ8 F) edeta te so dium (UNII: MP1J8 420 LU) butylene g lyco l (UNII: 3XUS8 5K0 RA) ka lmia la tifo lia lea f (UNII: 79 N6 542N18 ) yea st (UNII: 3NY3SM6 B8 U) vita min a pa lmita te (UNII: 1D1K0 N0 VVC) a sco rbyl pa lmita te (UNII: QN8 3US2B0 N) serine (UNII: 452VLY9 40 2) urea (UNII: 8 W8 T178 47W) a ca cia (UNII: 5C540 3N26 O) a lla nto in (UNII: 344S277G0 Z) so dium succina te a nhydro us (UNII: V8 ZGC8 ISR3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:1478 3-0 38 -6 1 1 in 1 BOX 1 NDC:1478 3-0 38 -6 2 50 g in 1 JAR Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC MONOGRAPH FINAL part352 0 8 /15/20 10 LBEL PARIS RENOVANCE JOUR octinoxate, octocrylene, and oxybenzone cream Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:1478 3-0 28 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength O ctino xa te (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51) Octino xate 0 .375 g in 5 g O cto crylene (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6 WM) Octo crylene 0 .25 g in 5 g O xybenzo ne (UNII: 9 5OOS7VE0 Y) (Oxybenzo ne - UNII:9 5OOS7VE0 Y) Oxybenzo ne 0 .15 g in 5 g Inactive Ingredients Ingredient Name Strength wa ter (UNII: 0 59 QF0 KO0 R) cyclo methico ne 6 (UNII: XHK3U310 BA) g lycerin (UNII: PDC6 A3C0 OX) sno w pea (UNII: 8 4SKC33B1I) c12 -15 a lkyl benzo a te (UNII: A9 EJ3J6 1HQ) medium-cha in trig lycerides (UNII: C9 H2L21V7U) cyclo methico ne 5 (UNII: 0 THT5PCI0 R) cetyl a lco ho l (UNII: 9 36 JST6 JCN) ceto stea ryl a lco ho l (UNII: 2DMT128 M1S) iso pro pyl myrista te (UNII: 0 RE8 K4LNJS) iso no nyl iso no na no a te (UNII: S4V5BS6 GCX) so rbita n mo no stea ra te (UNII: NVZ4I0 H58 X) ma nnito l (UNII: 3OWL53L36 A) g lyceryl mo no stea ra te (UNII: 230 OU9 XXE4) po ta ssium cetyl pho spha te (UNII: 0 3KCY6 P7UT) tro la mine (UNII: 9 O3K9 3S3TK) po lyo xyl 2 0 ceto stea ryl ether (UNII: YRC528 SWUY) pro pylpa ra ben (UNII: Z8 IX2SC1OH) pa ntheno l (UNII: WV9 CM0 O6 7Z) so dium pyrro lido ne ca rbo xyla te (UNII: 46 9 OTG57A2) stea reth-2 0 (UNII: L0 Q8 IK9 E0 8 ) ceteth-2 0 (UNII: I8 35H2IHHX) chlo rphenesin (UNII: I6 70 DAL4SZ) tita nium dio xide (UNII: 15FIX9 V2JP) tepreno ne (UNII: S8 S8 451A4O) po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H) po lyo xyl 4 0 hydro g ena ted ca sto r o il (UNII: 7YC6 8 6 GQ8 F) edeta te so dium (UNII: MP1J8 420 LU) butylene g lyco l (UNII: 3XUS8 5K0 RA) ka lmia la tifo lia lea f (UNII: 79 N6 542N18 ) yea st (UNII: 3NY3SM6 B8 U) vita min a pa lmita te (UNII: 1D1K0 N0 VVC) a sco rbyl pa lmita te (UNII: QN8 3US2B0 N) serine (UNII: 452VLY9 40 2) urea (UNII: 8 W8 T178 47W) a ca cia (UNII: 5C540 3N26 O) a lla nto in (UNII: 344S277G0 Z) so dium succina te a nhydro us (UNII: V8 ZGC8 ISR3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:1478 3-0 28 -51 1 in 1 BOX 1 NDC:1478 3-0 28 -52 5 g in 1 JAR Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC MONOGRAPH FINAL part352 0 8 /15/20 10 LBEL PARIS RENOVANCE JOUR octinoxate, octocrylene, and oxybenzone cream Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:1478 3-0 18 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength O ctino xa te (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51) Octino xate 0 .0 75 g in 1 g O cto crylene (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6 WM) Octo crylene 0 .0 5 g in 1 g O xybenzo ne (UNII: 9 5OOS7VE0 Y) (Oxybenzo ne - UNII:9 5OOS7VE0 Y) Oxybenzo ne 0 .0 3 g in 1 g Inactive Ingredients Ingredient Name Strength wa ter (UNII: 0 59 QF0 KO0 R) cyclo methico ne 6 (UNII: XHK3U310 BA) g lycerin (UNII: PDC6 A3C0 OX) sno w pea (UNII: 8 4SKC33B1I) c12 -15 a lkyl benzo a te (UNII: A9 EJ3J6 1HQ) medium-cha in trig lycerides (UNII: C9 H2L21V7U) cyclo methico ne 5 (UNII: 0 THT5PCI0 R) cetyl a lco ho l (UNII: 9 36 JST6 JCN) ceto stea ryl a lco ho l (UNII: 2DMT128 M1S) iso pro pyl myrista te (UNII: 0 RE8 K4LNJS) iso no nyl iso no na no a te (UNII: S4V5BS6 GCX) so rbita n mo no stea ra te (UNII: NVZ4I0 H58 X) ma nnito l (UNII: 3OWL53L36 A) g lyceryl mo no stea ra te (UNII: 230 OU9 XXE4) po ta ssium cetyl pho spha te (UNII: 0 3KCY6 P7UT) tro la mine (UNII: 9 O3K9 3S3TK) po lyo xyl 2 0 ceto stea ryl ether (UNII: YRC528 SWUY) pro pylpa ra ben (UNII: Z8 IX2SC1OH) pa ntheno l (UNII: WV9 CM0 O6 7Z) so dium pyrro lido ne ca rbo xyla te (UNII: 46 9 OTG57A2) stea reth-2 0 (UNII: L0 Q8 IK9 E0 8 ) ceteth-2 0 (UNII: I8 35H2IHHX) chlo rphenesin (UNII: I6 70 DAL4SZ) tita nium dio xide (UNII: 15FIX9 V2JP) tepreno ne (UNII: S8 S8 451A4O) po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H) po lyo xyl 4 0 hydro g ena ted ca sto r o il (UNII: 7YC6 8 6 GQ8 F) edeta te so dium (UNII: MP1J8 420 LU) butylene g lyco l (UNII: 3XUS8 5K0 RA) ka lmia la tifo lia lea f (UNII: 79 N6 542N18 ) yea st (UNII: 3NY3SM6 B8 U) vita min a pa lmita te (UNII: 1D1K0 N0 VVC) a sco rbyl pa lmita te (UNII: QN8 3US2B0 N) serine (UNII: 452VLY9 40 2) urea (UNII: 8 W8 T178 47W) a ca cia (UNII: 5C540 3N26 O) a lla nto in (UNII: 344S277G0 Z) so dium succina te a nhydro us (UNII: V8 ZGC8 ISR3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:1478 3-0 18 -41 1 in 1 BOX 1 NDC:1478 3-0 18 -42 1 g in 1 JAR Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC MONOGRAPH FINAL part352 0 8 /15/20 10 Labeler - Ventura International LT D (603192787) Revised: 8/2010 Ventura International LTD.