WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15- octinoxate, titanium dioxide emulsion

WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., Estee Lauder Cosmetics Ltd, Estee Lauder Cosmetics Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE 6.7%

TITANIUM DIOXIDE 1.6%

PURPOSE

SUNSCREEN

USE

helps prevent sunburn

Warnings

For external use only

Do not use

on damaged or broken 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 liberally 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, DIMETHICONE, GLYCERIN, TRIMETHYLSILOXYSILICATE, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, POLYGLYCERYL-3 DIISOSTEARATE, SODIUM CHLORIDE, ACETYL GLUCOSAMINE, DISTEARDIMONIUM HECTORITE, LAMINARIA SACCHARINA EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, LAVANDULA HYBRIDA OIL, HONEY EXTRACT\MEL\EXTRAIT DE MIEL, BUTYL AVOCADATE, CAPRYLYL GLYCOL, DISODIUM STEAROYL GLUTAMATE, SODIUM HYALURONATE, SALICYLIC ACID, METHOXY AMODIMETHICONE/SILSESQUIOXANE COPOLYMER, ALUMINUM HYDROXIDE, SILICA, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, POLYSILICONE-11, CITRIC ACID, SODIUM HYDROXIDE, HEXYLENE GLYCOL, STEARIC ACID, LINALOOL, LINALYL ACETATE, BHT, TOCOPHERYL ACETATE, DISODIUM EDTA, PHENOXYETHANOL, [+/- MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499)] <ILN52484>

Other information

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

PRINCIPAL DISPLAY PANEL

BOBBI

BROWN

Weightless Skin

foundation

Broad Spectrum

SPF 15

1FL. OZ. LIQ/30ml e

INGREDIENTS AND APPEARANCE

WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15 
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	17 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
BUTYL AVOCADATE (UNII: Q86RQ0D402)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
LAVANDIN OIL (UNII: 9RES347CKG)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
LINALYL ACETATE (UNII: 5K47SSQ51G)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LAVENDER OIL (UNII: ZBP1YXW0H8)
HONEY (UNII: Y9H1V576FH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-034-01	1 in 1 CARTON	05/16/2023
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 64141-034-02	1 in 1 CARTON	05/16/2023
2		13 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 final	M020	05/16/2023

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd		202952982	manufacture(64141-034)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	manufacture(64141-034) , pack(64141-034) , label(64141-034)