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)

PDP

SUNBETTER BROAD SPECTRUM SPF 75 SUNSCREEN TONE SMART 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62282-376
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62282-376-011 in 1 CARTON02/02/2021
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:62282-376-0215 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2021
3NDC:62282-376-031 mL in 1 PACKET; Type 0: Not a Combination Product02/01/2021
4NDC:62282-376-04237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2021
Labeler - Northwest Cosmetic Laboratories LLC, D.B.A. Elevation Labs Idaho (929572014)

Revised: 11/2022
Document Id: ec93e3c0-8ca1-a35e-e053-2995a90a5a3d
Set id: 76cdacdb-ba3c-42ec-8493-25cb94ff3f52
Version: 4
Effective Time: 20221103
 
Northwest Cosmetic Laboratories LLC, D.B.A. Elevation Labs Idaho