COLLAGEN GLOW CREME SPF 50- avobenzone, octisalate, octocrylene cream 
NAKED SUNDAYS PTY LTD

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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NAKED SUNDAYS COLLAGEN GLOW CREME SPF 50

ACTIVE INGREDIENTS

Avobenzone 3%
Octilsalate 5%
Octocrylene 10%

Purpose

Sunscreen

USES

WARNINGS

For external use only.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

SUN PROTECTION MEASURES

Spending time in the sun increases 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:

INACTIVE INGREDIENTS

Dimethicone 350, Ethylhexylglycerin, Glyceryl monostearate, Hydrolysed adansonia digitata leaf extract, Enzacamene, Hydrolysed rice protein, Hydrolysed soy protein, Phenoxyethanol, Potassium cetyl phosphate, Proline, Water (Aqua), Sodium benzoate, Sodium polyacrylate, Citrulius lanatus fruit extract (Watermelon).

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

label

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COLLAGEN GLOW CREME  SPF 50
avobenzone, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-101(NDC:30807-1006)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ADANSONIA DIGITATA LEAF (UNII: G75S8RQS56)  
ENZACAMENE (UNII: 8I3XWY40L9)  
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROLINE (UNII: 9DLQ4CIU6V)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
WATERMELON (UNII: 231473QB6R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81104-101-1150 mL in 1 TUBE; Type 0: Not a Combination Product11/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/19/2020
Labeler - NAKED SUNDAYS PTY LTD (746918845)

Revised: 9/2021
Document Id: cb80f6bb-f057-e1a9-e053-2a95a90aa670
Set id: 4deabe0f-af83-41b1-9484-70d950428259
Version: 3
Effective Time: 20210908
 
NAKED SUNDAYS PTY LTD