FRASE SKIN SPF 30 FACE SUNSCREEN ACTIVATED VITAMIN D TECHNOLOGY- avobenzone, octisalate, octocrylene cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient

Avobenzone 3.00%
Octisalate 5.00%
Octocrylene 5.00%

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.

Keep out of reach of children.

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

Other Information

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

Directions

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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.

Inactive Ingredients

Acetic Acid, Acetyl Hexapeptide-8, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Butyloctyl Salicylate, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Olivate, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Linoleic Acid, Pentanediol, Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Sodium Hyaluronate, Sodium Hydroxide, Sorbitan Olivate, Stearyl Alcohol, Thioctic Acid, Tocopherol, Water (Aqua)

Package Labeling:

INGREDIENTS AND APPEARANCE

FRASE SKIN SPF 30 FACE SUNSCREEN ACTIVATED VITAMIN D TECHNOLOGY 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87675-949
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	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
ACETYL HEXAPEPTIDE-8 AMIDE (UNII: L4EL31FWIL)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CUCUMBER (UNII: YY7C30VXJT)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER (UNII: 2788Z9758H)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87675-949-00	1 in 1 CARTON	05/04/2026
1		89 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/04/2026

Labeler - Frase Skin PTY LTD (144997480)

Registrant - Pure Source, LLC (080354456)