BORN THIS WAY HEALTHY GLOW SPF30- octinoxate,titanium dioxide,zinc oxide emulsion

BORN THIS WAY HEALTHY GLOW SPF30 by

Drug Labeling and Warnings

BORN THIS WAY HEALTHY GLOW SPF30 by is a Otc medication manufactured, distributed, or labeled by TOO FACED COSMETICS LLC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, NORTHTEC LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

OCTINOXATE 5.0%
TITANIUM DIOXIDE 3.1%
ZINC OXIDE 2.2%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

ON DAMAGED OR BRONKEN SKIN

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a
Poison Control Center right away.

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

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

TOO FACED
BORN THIS WAY
HEALTHY
GLOW
30 SPF
MOISTURIZING SKIN TINT
WATERMELON + APPLE
HYALURONIC ACID

BROAD SPECTRUM SPF 30

PROTECTS AGAINST
UVA & UVB RAYS
60ML / 2.0 FL. OZ.

INGREDIENTS AND APPEARANCE

BORN THIS WAY HEALTHY GLOW SPF30 
octinoxate,titanium dioxide,zinc oxide emulsion

Product 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)