- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
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DIRECTIONS
Apply liberally and evenly 15 minutes before sun exposure. 1Reapply:
At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours.
- 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 a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses.
- 1
- For children under 6 months of age: Ask a doctor.
- 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 a broad spectrum SPF of 15 or higher and other sun protection measures including:
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INACTIVE INGREDIENTS
Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.
- OTHER INFORMATION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
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INGREDIENTS AND APPEARANCE
DAILY FACE MOISTURIZER
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66163-2612 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 70 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 40 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Isocetyl Stearate (UNII: 3RJ7186O9W) Sorbitol (UNII: 506T60A25R) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cyclomethicone 5 (UNII: 0THT5PCI0R) Glyceryl Monostearate (UNII: 230OU9XXE4) PEG-100 Stearate (UNII: YD01N1999R) Alcohol (UNII: 3K9958V90M) Octisalate (UNII: 4X49Y0596W) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3) Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) Ethylhexylglycerin (UNII: 147D247K3P) Betula Pubescens Bark (UNII: 3R504894L9) Garden Cress Sprout (UNII: PWQ18YNR62) Sage (UNII: 065C5D077J) Cola Acuminata Seed (UNII: 1F8VIW1479) Camellia Oleifera Leaf (UNII: 5077EL0C60) Aloe Vera Leaf (UNII: ZY81Z83H0X) Xanthan Gum (UNII: TTV12P4NEE) Isomalt (UNII: S870P55O2W) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Triethoxycaprylylsilane (UNII: LDC331P08E) Sodium Benzoate (UNII: OJ245FE5EU) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66163-2612-8 60 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2016 Labeler - Cosmetic Solutions LLC (807907928)