SUNBETTER BROAD SPECTRUM SPF 70 SUNSCREEN SHEER- zinc oxide, titanium dioxide lotion
Northwest Cosmetic Laboratories, LLC D.B.A Elevation Labs Idaho

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.

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sunbetter Broad Spectrum SPF 70 Sunscreen Lotion Sheer

Principal Display Panel

sunbetter™

Advanced Mineral Protection

BROAD SPECTRUM SPF 70

SUNSCREEN LOTION

SHEER

Water-Resistant (80 Minutes)

Mineral Actives

skinbetter science®

1.7 FL.OZ. (50 ML)

PDP

SUNBETTER BROAD SPECTRUM SPF 70 SUNSCREEN SHEER
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62282-377
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	36 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM OXIDE (UNII: LMI26O6933)
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CERIC OXIDE (UNII: 619G5K328Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SQUALANE (UNII: GW89575KF9)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
PANTHENOL (UNII: WV9CM0O67Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62282-377-01	1 in 1 CARTON	02/02/2021
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC:62282-377-02	15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2021
3	NDC:62282-377-03	1 mL in 1 PACKET; Type 0: Not a Combination Product	02/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2021

Labeler - Northwest Cosmetic Laboratories, LLC D.B.A Elevation Labs Idaho (929572014)