Label: ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA- octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-421-01 - Packager: Jafra Cosmetics International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply 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 value of 15 or higher and other sun
protection measures including:• limit your time in the sun, especially from 10
a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses• Children under 6 months of age: ask a doctor.
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INACTIVE INGREDIENT
Inactive ingredients
C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Dimethicone, Dimethicone Crosspolymer, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcocoate PEG-8 Dimethicone, Iron Oxides/CI 77491/CI 77492/CI 77499, Kaolin, Lecithin, Methicone, Phenoxyethanol, Phenyl Trimethicone, Propylene carbonate, Silica, Silica Dimethyl Silylate, Sodium Chloride, Stoddard solvent, Titanium Dioxide/CI 77891, Triethoxycaprylysilane, Water/Aqua
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALWAYS FOUNDATION MAKEUP BROAD SPECTRUM SPF 15 COCOA
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-421 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.8 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength METHICONE (20 CST) (UNII: 6777U11MKT) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) WHITE SPIRIT TYPE 1 (UNII: 37LNJ1I16R) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM CHLORIDE (UNII: 451W47IQ8X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) FERROSOFERRIC OXIDE (UNII: XM0M87F357) KAOLIN (UNII: 24H4NWX5CO) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PROPYLENE CARBONATE (UNII: 8D08K3S51E) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-421-01 30 mL in 1 CARTON; Type 0: Not a Combination Product 07/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/14/2020 Labeler - Jafra Cosmetics International (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-421)
