SPL v1
SPL
SPL Set ID 8153c706-d1bd-6c42-e053-2991aa0afda4
Route
TOPICAL
Published
Effective Date 2019-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octinoxate (7.5 g) Octisalate (5 g) Octocrylene (2.7 g) Oxybenzone (4 g)
Inactive Ingredients
Butylene Glycol Isostearyl Neopentanoate Ppg-2 Isoceteth-20 Acetate Poly(methyl Methacrylate; 450000 Mw) Bakuchiol Vitamin A Palmitate .alpha.-tocopherol Acetate Levomenol Cetostearyl Alcohol Sorbitan Monooleate Retinol Hydroxypinacolone Retinoate Myristoyl Pentapeptide-4 Palmitoyl Tetrapeptide-7 Tocopherol Sodium Ascorbate Hyaluronate Sodium Medium-chain Triglycerides Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Docosanol Sodium Lactate Ethylhexylglycerin Isohexadecane Polysorbate 80 Polysorbate 20 Dimethyl Isosorbide Xanthan Gum Polyacrylic Acid (8000 Mw) Edetate Disodium Sodium Hydroxide Pentylene Glycol Chlorphenesin Phenoxyethanol Caprylyl Glycol Citric Acid Monohydrate Potassium Sorbate Water Glycerin Dimethicone Ethylhexyl Methoxycrylene Neopentyl Glycol Diheptanoate Glyceryl Stearate Se

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-21
Description

Avobenzone 3%., Octinoxate 7.5%, Octisalate 5%,Octocrylene 2.7%,Oxybenzone 4%.

Medication Information

Description

Avobenzone 3%., Octinoxate 7.5%, Octisalate 5%,Octocrylene 2.7%,Oxybenzone 4%.

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

Section 50565-1

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

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 3%., Octinoxate 7.5%, Octisalate 5%,Octocrylene 2.7%,Oxybenzone 4%.

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.

Directions

For sunscreen use: • apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating. 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 factor of 15 or higher and other skin protection measures including:

• limit time in the sun, especially from 10am to 2pm

• wear long-sleeved shirts, pants, hats and sunglasses

• children under 6 months of age: ask a doctor

Inactive Ingredients

Water, Glycerin, Dimethicone, Ethylhexyl Methoxycrylene, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Butylene Glycol, Isostearyl Neopentanoate, PPG-2 Isoceteth-20 Acetate, Polymethyl Methacrylate, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Bakuchiol, Retinyl Palmitate, Tocopheryl Acetate, Bisabolol, Cetearyl Alcohol, Sorbitan Oleate, Retinol, Hydroxypinacolone Retinoate, Myristoyl Nanapeptide-3, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Tocopherol, Sodium Ascorbate, Sodium Hyaluronate, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Sodium Lactate, Ethylhexylglycerin, Isohexadecane, Polysorbate 80, Polysorbate 20, Dimethyl Isosorbide, Xanthan Gum, Carbomer, Disodium EDTA, Sodium Hydroxide, Pentylene Glycol, Chlorphenesin, Phenoxyethanol, Caprylyl Glycol, Citric Acid, Potassium Sorbate, Fragrance.

Structured Label Content

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

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 3%., Octinoxate 7.5%, Octisalate 5%,Octocrylene 2.7%,Oxybenzone 4%.

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.

Directions

For sunscreen use: • apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating. 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 factor of 15 or higher and other skin protection measures including:

• limit time in the sun, especially from 10am to 2pm

• wear long-sleeved shirts, pants, hats and sunglasses

• children under 6 months of age: ask a doctor

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Dimethicone, Ethylhexyl Methoxycrylene, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Butylene Glycol, Isostearyl Neopentanoate, PPG-2 Isoceteth-20 Acetate, Polymethyl Methacrylate, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Bakuchiol, Retinyl Palmitate, Tocopheryl Acetate, Bisabolol, Cetearyl Alcohol, Sorbitan Oleate, Retinol, Hydroxypinacolone Retinoate, Myristoyl Nanapeptide-3, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Tocopherol, Sodium Ascorbate, Sodium Hyaluronate, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Sodium Lactate, Ethylhexylglycerin, Isohexadecane, Polysorbate 80, Polysorbate 20, Dimethyl Isosorbide, Xanthan Gum, Carbomer, Disodium EDTA, Sodium Hydroxide, Pentylene Glycol, Chlorphenesin, Phenoxyethanol, Caprylyl Glycol, Citric Acid, Potassium Sorbate, Fragrance.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:45.579451 · Updated: 2026-03-14T22:55:26.303656