FRASE SKIN SPF 50 ACTIVATED VITAMIN D TECHNOLOGY COOL- avobenzone, octisalate, octocrylene liquid

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient

Avobenzone 3.00%
Octisalate 5.00%
Octocrylene 10.00%

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 aging 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 or irritation develops and lasts.

Do not puncture or incinerate.Contents under pressure. Do not store it at temperatures above 120°F.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use

Directions

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months: ask a doctor.
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• do not spray directly on face. Spray into hands and apply to face. 
• Use in well-ventilated areas.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum of SPF of 15 or higher and other sun protection measures including: 
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

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

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Alcohol, Aloe Barbadensis Leaf Extract, Ascorbyl Palmitate, Butyloctyl Salicylate, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Fragrance (Parfum), Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate

Package Labeling:

INGREDIENTS AND APPEARANCE

FRASE SKIN SPF 50 ACTIVATED VITAMIN D TECHNOLOGY COOL 
avobenzone, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87675-959
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87675-959-00	177 mL in 1 CAN; Type 0: Not a Combination Product	04/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/23/2026

Labeler - Frase Skin PTY LTD (144997480)

Registrant - Pure Source, LLC (080354456)