BAIN DE SOLEIL MEGA TAN SPF 4- octinoxate and octocrylene lotion Bayer HealthCare LLC. 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. ------Bain de Soleil ®
Mega Tan ® SPF 4 Drug Facts
Active ingredient Octinoxate 3.5%, Octocrylene 1%
Purpose Sunscreen
Use helps prevent sunburn
Warnings
Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions use sparingly around hairline and eyebrows. Blend completely to avoid streaking. Wash and wipe hands immediately after each application
For Sunscreen Use apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: Ask a doctor
Other information protect this product from excessive heat and direct sun may stain or damage some fabrics or surfaces
store at or below room temperature
Inactive ingredients water, butylene glycol, cyclopentasiloxane, polyquaternium-37, mineral oil, PPG-1 trideceth-6, VP/eicosene copolymer, isohexadecane, tribehenin, cetyl palmitate, fragrance, distearyldimonium chloride, aloe barbadensis leaf extract, eucalyptus globulus leaf extract, prunus armeniaca (apricot) fruit extract, chamomilla recutita (matricaria) flower extract, theobroma cacao (cocoa) extract, elaeis guineensis (palm) kernel oil, lanolin, iodopropynyl butylcarbamate, DMDM hydantoin, cetyl alcohol, cetyl hydroxyethylcellulose, disodium EDTA, dihydroxyacetone
Questions? 866-288-3330
PRINCIPAL DISPLAY PANEL - 118 mL Tube Carton BAIN de SOLEIL ® MEGA TAN ® 4 spf sunscreen with self tanner faster, darker tan contains a self tanner moisturizers & botanicals 4 FL OZ (118mL) BAIN DE SOLEIL MEGA TAN SPF 4 octinoxate and octocrylene lotion Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:11523-70 9 4 Route of Administration TOPICAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 35 mg in 1 mL O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM) OCTOCRYLENE 10 mg in 1 mL
Inactive Ingredients Ingredient Name Strength WATER (UNII: 0 59 QF0 KO0 R) BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA) CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R) MINERAL O IL (UNII: T5L8 T28 FGP) PPG-1 TRIDECETH-6 (UNII: 1K7417JX6 Q) ISO HEXADECANE (UNII: 9 18 X1OUF1E) TRIBEHENIN (UNII: 8 OC9 U7TQZ0 ) CETYL PALMITATE (UNII: 5ZA2S6 B0 8 X) DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 ) APRICO T (UNII: 26 9 CJD5GZ9 ) CHAMO MILE (UNII: FGL36 8 5T2X) CO CO A (UNII: D9 10 8 TZ9 KG) PALM KERNEL O IL (UNII: B0 S9 0 M0 233) LANO LIN (UNII: 7EV6 5EAW6 H) IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB) DMDM HYDANTO IN (UNII: BYR0 546 TOW) CETYL ALCO HO L (UNII: 9 36 JST6 JCN) EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K) DIHYDRO XYACETO NE (UNII: O10 DDW6 JOO)
Product Characteristics Color white (o ff white) Score Shape Siz e Flavor Imprint Code Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-70 9 4-1 1 in 1 CARTON 0 5/21/19 9 9 1 118 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part352 0 5/21/19 9 9
Labeler - Bayer HealthCare LLC. (112117283)
Revised: 11/2019 Bayer HealthCare LLC.