Label: COLLAGEN GLOW MINERAL SUNSCREEN SPF 50- zinc oxide lotion
- NDC Code(s): 81104-103-11, 81104-103-12, 81104-103-13
- Packager: NAKED SUNDAYS PTY LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 31, 2024
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- ACTIVE INGREDIENT
- USES
- WARNINGS
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DIRECTIONS
- APPLY GENEROUSLY 15 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
CETEARYL GLUCOSIDE, CETOSTEARYL ALCOHOL, COCO-CAPRYLATE, DISODIUM EDETATE, GLUCONOLACTONE, HYDROLYZED ADANSONIA DIGITATA SEED EXTRACT, HYDROLYZED RICE PROTEIN, HYDROLYZED SOY PROTEIN, ISOSTEARIC ACID, CAPRIC TRIGLYCERIDES, OCTYLDODECANOL, PEG-30 DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3 POLYRICINOLEATE, PROLINE, WATER (AQUA), SODIUM BENZOATE, SODIUM CHLORIDE.
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 22.75 g in 100 mL Inactive Ingredients Ingredient Name Strength CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCO-CAPRYLATE (UNII: 4828G836N6) EDETATE DISODIUM (UNII: 7FLD91C86K) GLUCONOLACTONE (UNII: WQ29KQ9POT) ADANSONIA DIGITATA SEED (UNII: 2936P60TPX) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) ISOSTEARIC ACID (UNII: X33R8U0062) TRICAPRIN (UNII: O1PB8EU98M) OCTYLDODECANOL (UNII: 461N1O614Y) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) PROLINE (UNII: 9DLQ4CIU6V) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81104-103-11 50 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2020 2 NDC:81104-103-12 20 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2020 3 NDC:81104-103-13 80 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/01/2020 Labeler - NAKED SUNDAYS PTY LTD (746918845)