COLLAGEN GLOW MINERAL SUNSCREEN SPF 50: Package Insert and Label Information

COLLAGEN GLOW MINERAL SUNSCREEN SPF 50- zinc oxide lotion
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.

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.

Label

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COLLAGEN GLOW MINERAL SUNSCREEN SPF 50
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-103(NDC:30807-1008)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 22.75 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CETEARYL GLUCOSIDE
CETOSTEARYL ALCOHOL
COCO-CAPRYLATE
EDETATE DISODIUM
GLUCONOLACTONE
ADANSONIA DIGITATA SEED
ORYZA SATIVA WHOLE
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)
ISOSTEARIC ACID
TRICAPRIN
OCTYLDODECANOL
PEG-30 DIPOLYHYDROXYSTEARATE
POLYGLYCERYL-3 RICINOLEATE
PROLINE
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81104-103-11 50 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/01/2020
Labeler — NAKED SUNDAYS PTY LTD (746918845)

Revised: 09/2021 NAKED SUNDAYS PTY LTD

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