CLEAR SUNSCREEN SPF 30 BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene gel 
Cremo company

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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Clear Sunscreen SPF 30 Broad Spectrum

Active ingredients Purpose

Avobenzone 3% Sunscreen

Homoslatate 15% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 2.79% Sunscreen

Uses

Stop use and ask a doctor if rash occurs.

Warnings

Directions

Inactive ingredients Butyloctyl Salicylate, Capric/Caprylic Triglyceride, Dicaprylyl Ether, DImethicone/Bis-Isobutyl PPG-20 Crosspolymer, Fragrance, Isododecane, Methyl Dihydroabietate, Silica.

Cremo Clear Sunscreen

for face, hairline & Scalp

SPF 30 Broad Spectrum

2 FL OZ (59mL)

Box

label

CLEAR SUNSCREEN SPF 30 BROAD SPECTRUM 
avobenzone, homosalate, octisalate, octocrylene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71825-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.79 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISODODECANE (UNII: A8289P68Y2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71825-101-0159 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/07/2019
Labeler - Cremo company (078708508)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose, Inc.083819404manufacture(71825-101)

Revised: 1/2019
Document Id: 7ee3dbbd-d1e3-152d-e053-2991aa0a9c2f
Set id: 7ee3dbbd-d1e2-152d-e053-2991aa0a9c2f
Version: 1
Effective Time: 20190107
 
Cremo company