SUNSCREEN- homosalate, octocrylene, octisalate, avobenzone gel 
Oxygen Development, LLC

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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Broad Spectrum Sunscreen Clear as Day SPF 46 Starface

Active ingredient

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Uses

Helps prevent sunburn. If used as directed with another sun protection measures (see Directions), decreasses the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only. Do not use on damage or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rigth away

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Reapply at least every 2 hours.

Sun protection meassures: Spending time in the sun increasses 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, specially from 10 am - 2 pm, wear long-sleeved shirts, pants, hats and sunglasses.

Inactive ingredients

Isododecane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, VP/Eicosene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

Package

61354-047-01_AW

Package

61354-047-02_AW

Package

61354-047-04_aw61354-047-03_AW

SUNSCREEN 
homosalate, octocrylene, octisalate, avobenzone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-047
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ISODODECANE (UNII: A8289P68Y2) 49.8 mg  in 100 mg
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) 2 mg  in 100 mg
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 2.85 mg  in 100 mg
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) 1.25 mg  in 100 mg
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 2 mg  in 100 mg
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 12.46 mg  in 100 mg
ALUMINUM HEXAFLUOROSILICATE NONAHYDRATE (UNII: L5630XRC87) 1.5 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-047-041 in 1 PACKAGE02/14/2022
1NDC:61354-047-031 in 1 CARTON
1NDC:61354-047-021 in 1 PACKAGE
1NDC:61354-047-01100 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/14/2022
Labeler - Oxygen Development, LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development, LLC137098492manufacture(61354-047)

Revised: 2/2023
Document Id: f3cf2641-92cd-67b2-e053-2a95a90ab73b
Set id: d7fe4990-507e-4062-e053-2a95a90ae6d9
Version: 2
Effective Time: 20230203
 
Oxygen Development, LLC