Label: WOLF DAILY MOISTURIZIER SPF 15- octinoxate, oxybenzone, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 63148-008-04 - Packager: Apollo Health and Beauty Care Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 1, 2018
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- Active ingredients
- Use(s)
- Warnings
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Directions
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measure including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses.
- use a water resistant sunscreen if swimming or sweating.
- reapply at least every 2 hours.
- children under 6 months: ask doctor
- Other information
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Inactive ingredients
Water (Aqua), Butylene Glycol Cocoate, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Glycerin, Acetamidoethoxyethanol, Potassium Cetyl Phosphate, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Polysorbate 80, Isohexadecane, Benzyl Alcohol, Xanthan Gum, Tetrasodium Glutamate Diacetate, Fragrance (Parfum), Lactic Acid, Triethoxycaprylylsilane, Tetrahexydecyl Ascorbate, Crambe Abyssinica Seed Oil, Panthenol, Hydrolyzed Keratin, Camellia Sinensis Leaf Extract, Aspalathus Linearis Leaf Extract, Aloe Barbadensis Leaf Juice, Pinus Pinaster Bark Extract, Hydrolyzed Adansonia Digitata Seed Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hydrolyzed Hemp Protein, Hydrolyzed Vegetable Protein, Ascorbyl Glucoside, Phytonadione, Niacinamide, Cyanocobalamin, Tocopheryl Acetate, Iodopropynyl Butylcarbamate.
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INGREDIENTS AND APPEARANCE
WOLF DAILY MOISTURIZIER SPF 15
octinoxate, oxybenzone, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 20 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 38 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ISOHEXADECANE (UNII: 918X1OUF1E) BENZYL ALCOHOL (UNII: LKG8494WBH) XANTHAN GUM (UNII: TTV12P4NEE) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) LACTIC ACID (UNII: 33X04XA5AT) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PANTHENOL (UNII: WV9CM0O67Z) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) ALOE VERA LEAF (UNII: ZY81Z83H0X) MARITIME PINE (UNII: 50JZ5Z98QY) ADANSONIA DIGITATA SEED (UNII: 2936P60TPX) TEA TREE OIL (UNII: VIF565UC2G) CANNABIS SATIVA SEED (UNII: QE567Z26NG) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) PHYTONADIONE (UNII: A034SE7857) NIACINAMIDE (UNII: 25X51I8RD4) CYANOCOBALAMIN (UNII: P6YC3EG204) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63148-008-04 118 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2018 Labeler - Apollo Health and Beauty Care Inc. (201901209) Registrant - Apollo Health and Beauty Care Inc. (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc. 201901209 manufacture(63148-008)
