Label: COLLAGEN GLOW CREME SPF 50- avobenzone, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81104-101-11 - Packager: NAKED SUNDAYS PTY LTD
- This is a repackaged label.
- Source NDC Code(s): 30807-1006
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 8, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- USES
- WARNINGS
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DIRECTIONS
- Apply generously15 minutes before sun exposure.
- Reapply after 80 minutes of swimming or sweating.
- Reapply immediately after towel drying.
- Reapply at least every 2 hours.
- Children under 3 years of age: Ask a doctor.
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:
- Limit time in the sun, especially from 10.00AM - 2.00PM
- Wear long-sleeved shirts, pants, hats, and sunglasses
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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
- label
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INGREDIENTS AND APPEARANCE
COLLAGEN GLOW CREME SPF 50
avobenzone, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-101(NDC:30807-1006) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:81104-101-11 50 mL in 1 TUBE; Type 0: Not a Combination Product 11/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/19/2020 Labeler - NAKED SUNDAYS PTY LTD (746918845)
