Label: BORN THIS WAY HEALTHY GLOW SPF30- octinoxate,titanium dioxide,zinc oxide emulsion
- NDC Code(s): 79596-006-01
- Packager: TOO FACED COSMETICS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
-
Directions
For sunscreen use:
• apply generously and evenly 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• 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 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
-
Inactive Ingredients
WATER\AQUA\EAU [] METHYL TRIMETHICONE [] PHENYL TRIMETHICONE [] SILICA [] BUTYLOCTYL SALICYLATE [] DIMETHICONE [] NEOPENTYL GLYCOL DIHEPTANOATE [] C12-15 ALKYL BENZOATE [] BUTYLENE GLYCOL [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] ETHYLHEXYL PALMITATE [] TRIMETHYLSILOXYSILICATE/DIMETHICONOL CROSSPOLYMER [] GLYCERIN [] POLYSILICONE-11 [] RHODODENDRON FERRUGINEUM EXTRACT [] COCOS NUCIFERA (COCONUT) LIQUID ENDOSPERM [] COCOS NUCIFERA (COCONUT) FRUIT JUICE [] SODIUM HYALURONATE [] THERMUS THERMOPHILLUS FERMENT [] SODIUM PCA [] PYRUS MALUS (APPLE) FRUIT EXTRACT [] LENS ESCULENTA (LENTIL) FRUIT EXTRACT [] CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT [] TOCOPHERYL ACETATE [] LITCHI CHINENSIS SEED EXTRACT [] LECITHIN [] SODIUM LACTATE [] TRIETHYL CITRATE [] PEG-10 DIMETHICONE [] MAGNESIUM ALUMINUM SILICATE [] DIMETHICONE SILYLATE [] DEXTRIN [] TRIETHOXYCAPRYLYLSILANE [] SILICA DIMETHYL SILYLATE [] TRIMETHYLSILOXYSILICATE [] DISODIUM PHOSPHATE [] LAURETH-7 [] DISTEARDIMONIUM HECTORITE [] SODIUM CHLORIDE [] DIMETHICONE/PEG-10/15 CROSSPOLYMER [] XANTHAN GUM [] CALCIUM CHLORIDE [] CAPRYLYL GLYCOL [] DIPROPYLENE GLYCOL [] HEXYLENE GLYCOL [] LAMINARIA SACCHARINA EXTRACT [] GLYCINE SOJA (SOYBEAN) PROTEIN [] POLYGLUTAMIC ACID [] ZINC STEARATE [] BHT [] DISODIUM EDTA [] SODIUM CITRATE [] PHENOXYETHANOL [] POTASSIUM SORBATE [] SODIUM DEHYDROACETATE [] SODIUM BENZOATE [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491) [] IRON OXIDES (CI 77492) [] IRON OXIDES (CI 77499)] <ILN48852>
- Other Information
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BORN THIS WAY HEALTHY GLOW SPF30
octinoxate,titanium dioxide,zinc oxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79596-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 31 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22 mg in 1 mL Inactive Ingredients Ingredient Name Strength RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU) LENS CULINARIS FRUIT (UNII: ZYZ076G9JH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) ETHYLHEXYL PALMITATE (UNII: 2865993309) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) DIPROPYLENE GLYCOL (UNII: E107L85C40) SOY PROTEIN (UNII: R44IWB3RN5) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) GLYCERIN (UNII: PDC6A3C0OX) COCONUT JUICE (UNII: AMN6S4M09G) HYALURONATE SODIUM (UNII: YSE9PPT4TH) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) APPLE (UNII: B423VGH5S9) WATERMELON (UNII: 231473QB6R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LITCHI CHINENSIS SEED (UNII: 9294024N9Q) PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) LAURETH-7 (UNII: Z95S6G8201) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55) ZINC STEARATE (UNII: H92E6QA4FV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) DIMETHICONE (UNII: 92RU3N3Y1O) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) COCONUT WATER (UNII: 267F5Y81NT) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SODIUM LACTATE (UNII: TU7HW0W0QT) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) ICODEXTRIN (UNII: 2NX48Z0A9G) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79596-006-01 1 in 1 CARTON 01/12/2023 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/12/2023 Labeler - TOO FACED COSMETICS LLC (014131481) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 label(79596-006) , pack(79596-006) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 manufacture(79596-006) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 label(79596-006) , pack(79596-006) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 label(79596-006) , pack(79596-006) , manufacture(79596-006) Establishment Name Address ID/FEI Business Operations NORTHTEC LLC 943871157 label(79596-006) , pack(79596-006) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 label(79596-006) , pack(79596-006)
TOO FACED