sunbetter Broad Spectrum SPF 75 Sunscreen Lotion Tone Smart

sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart by

Drug Labeling and Warnings

sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart by is a Otc medication manufactured, distributed, or labeled by Northwest Cosmetic Laboratories LLC, D.B.A. Elevation Labs Idaho. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNBETTER BROAD SPECTRUM SPF 75 SUNSCREEN TONE SMART- 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 75 Sunscreen Lotion Tone Smart

Principal Display Panel

sunbetter™

Advanced Mineral Protection

BROAD SPECTRUM SPF 75

SUNSCREEN LOTION

TONE SMART

Water-Resistant (80 Minutes)

Mineral Actives

skinbetter science®

1.7 FL.OZ. (50 ML)

SUNBETTER BROAD SPECTRUM SPF 75 SUNSCREEN TONE SMART 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62282-376
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	35 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
GINGER (UNII: C5529G5JPQ)
ALLANTOIN (UNII: 344S277G0Z)
ALUMINUM OXIDE (UNII: LMI26O6933)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
UBIDECARENONE (UNII: EJ27X76M46)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CAPER BERRY (UNII: 7G4C45EE8C)
CERIC OXIDE (UNII: 619G5K328Y)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
NIACINAMIDE (UNII: 25X51I8RD4)
BLACK OLIVE (UNII: 2M6QWV94OC)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
PANTHENOL (UNII: WV9CM0O67Z)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TROPOLONE (UNII: 7L6DL16P1T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62282-376-01	1 in 1 CARTON	02/02/2021
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 62282-376-02	15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2021
3	NDC: 62282-376-03	1 mL in 1 PACKET; Type 0: Not a Combination Product	02/01/2021
4	NDC: 62282-376-04	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2021

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

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

Revised: 11/2022

Document Id: ec93e3c0-8ca1-a35e-e053-2995a90a5a3d

34390-5

Set id: 76cdacdb-ba3c-42ec-8493-25cb94ff3f52

Version: 4

Effective Time: 20221103

 

Northwest Cosmetic Labor