COLLAGEN GLOW CREME SPF 50- avobenzone, octisalate, octocrylene cream

COLLAGEN GLOW CREME by

Drug Labeling and Warnings

COLLAGEN GLOW CREME by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAYS PTY LTD, WILD CHILD W A PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 3%
Octilsalate 5%
Octocrylene 10%

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.
• Keep out of reach of children: If product is swallowed, get medical help.

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

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

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

INGREDIENTS AND APPEARANCE

COLLAGEN GLOW CREME  SPF 50
avobenzone, octisalate, octocrylene cream

Product 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)