COLLAGEN GLOW MINERAL SUNSCREEN SPF 50- zinc oxide lotion

COLLAGEN GLOW MINERAL SUNSCREEN by

Drug Labeling and Warnings

COLLAGEN GLOW MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAYS PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 22.75%

Purpose

Sunscreen

USES

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin ageing caused by the sun.

WARNINGS

For external use only.

• Do not use on damaged or broken skin.
• When using this product: keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor if: rash occurs.

• CONTAINS SODIUM BENZOATE.

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

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLLAGEN GLOW MINERAL SUNSCREEN  SPF 50
zinc oxide lotion

Product 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)