Avobenzone, Homosalate, Octocrylene, Octyl Salicylate Lotion the Hain Celestial Group, Inc
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ALBA BOTANICA PURE LAVENDER SUNSCREEN SPF45- avobenzone, homosalate, octocrylene, octyl salicylate lotion The Hain Celestial Group, Inc. 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. ---------- Active Ingredient Avobenzone - 3.0% Homosalate - 10.0% Octocrylene - 10.0% Ethylhexyl Salicylate - 5.0% Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Sunscreen 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 skin rash occurs. Keep out of reach of children. If swallowed get medical help or contact Poison Center right away. Water (Aqua), Homosalate, Octocrylene, Octisalate, Cetyl Alcohol, Glycerin, Avobenzone, Glyceryl Stearate SE, Dimethicone, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Myroxylon Pereirae (Balsam Peru) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Aloe Barbadensis Leaf Juice *, Calendula Officinalis Flower Extract *, Camellia Sinensis Leaf Extract *, Chamomilla Recutita (Matricaria) Flower Extract *, Citrus Aurantium Dulcis (Orange) Fruit Extract, Echinacea Angustifolia Extract *, Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract *, Panax Ginseng Root Extract, Tocopheryl Acetate, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Vanillin, Xanthan Gum, Alcohol *, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool. * Certified Organicf Ingredient Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases. ALBA BOTANICA PURE LAVENDER SUNSCREEN SPF45 avobenzone, homosalate, octocrylene, octyl salicylate lotion Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 19 9 5-20 9 3 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S) HOMOSALATE 10 g in 10 0 g O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W) OCTISALATE 5 g in 10 0 g O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM) OCTOCRYLENE 10 g in 10 0 g AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX) AVOBENZONE 3 g in 10 0 g Inactive Ingredients Ingredient Name Strength LIMO NENE, (+/-)- (UNII: 9 MC3I34447) ECHINACEA ANGUSTIFO LIA (UNII: VB0 6 AV5US8 ) VANILLIN (UNII: CHI530 446 X) LAVENDER O IL (UNII: ZBP1YXW0 H8 ) LAVANDULA ANGUSTIFO LIA FLO WER (UNII: 19 AH1RAF4M) ALCO HO L (UNII: 3K9 9 58 V9 0 M) BENZYL ALCO HO L (UNII: LKG8 49 4WBH) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) GLYCERIN (UNII: PDC6 A3C0 OX) WATER (UNII: 0 59 QF0 KO0 R) VINYLPYRRO LIDO NE/HEXADECENE CO PO LYMER (UNII: KFR5QEN0 N9 ) SO DIUM STEARO YL GLUTAMATE (UNII: 6 5A9 F4P0 24) .ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 ) GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I) PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4) CETYL ALCO HO L (UNII: 9 36 JST6 JCN) DIMETHICO NE (UNII: 9 2RU3N3Y1O) GREEN TEA LEAF (UNII: W2ZU1RY8 B0 ) CHAMO MILE (UNII: FGL36 8 5T2X) XANTHAN GUM (UNII: TTV12P4NEE) CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S) PO LYSO RBATE 6 0 (UNII: CAL22UVI4M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U) CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD) GINKGO (UNII: 19 FUJ2C58 T) CETEARYL O LIVATE (UNII: 58 B6 9 Q8 4JO) SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) SO RBITAN O LIVATE (UNII: MDL271E3GR) SO DIUM BENZO ATE (UNII: OJ245FE5EU) O RANGE O IL (UNII: AKN3KSD11B) CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) LAVANDIN O IL (UNII: 9 RES347CKG) RO SEMARY O IL (UNII: 8 LGU7VM39 3) ASIAN GINSENG (UNII: CUQ3A77YXI) BALSAM PERU O IL (UNII: DIK0 39 56 79 ) LINALO O L, (+/-)- (UNII: D8 1QY6 I8 8 E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:6 19 9 5-20 9 3-1 28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct 0 8 /24/20 17 Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part352 0 8 /24/20 17 Labeler - T he Hain Celestial Group, Inc. (117115556) Registrant - T he Hain Celestial Group, Inc. (014334364) Establishment Name Addre ss ID/FEI Busine ss Ope rations The Hain Celestial Gro up, Inc. 0 1433436 4 manufacture(6 19 9 5-20 9 3) Revised: 8/2019 The Hain Celestial Group, Inc..