SPL v1
SPL
SPL Set ID 3c49c623-47c6-4dc9-e063-6294a90a0096
Route
TOPICAL
Published
Effective Date 2025-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.5 g) Octocrylene (7.5 g) Oxybenzone (3.5 g)
Inactive Ingredients
Hydrogenated Polyisobutene (450 Mw) Hydrated Silica Water Butyloctyl Salicylate Alpha-tocopherol Acetate Microcrystalline Wax Polyethylene Beeswax Isohexadecane Dimethicone Caprylyl Glycol Phenoxyethanol Aloe Barbadensis Leaf Powder Ethylhexyl Palmitate Edetate Disodium Chlorphenesin Lauryl Peg-8 Dimethicone (300 Cps) Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-31

Description

Avobenzone 2.5%, Octocrylene 7.5%, Oxybenzone 3.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.5%, Octocrylene 7.5%, Oxybenzone 3.5%

Uses

■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

May stain some fabrics and surfaces.

Directions

■ Apply liberally 15 minutes before sun exposure ■ 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 this risk, regularly use 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 a.m. – 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor

Do Not Use

■ on damaged or broken skin.

Other Information

■protect the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 2.5%, Octocrylene 7.5%, Oxybenzone 3.5%

Inactive Ingredients:

Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate, Ethylhexyl Palmitate, Dimethicone, Hydrated Silica, Sodium Chloride, Phenoxyethanol, Beeswax, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Isohexadecane, Microcrystalline Wax, Polyethylene, Chlorphenesin, Caprylyl Glycol, Disodium EDTA, Stearoxy Dimethicone, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

When Using This Product

■ keep out of eyes. Rinse with water to remove.

Prinicipal Display Panel

BANANA

BOAT

KIDS

MAX PROTECT & PLAY

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 100

100

PROTECTS

FROM 99%

OF BURNING RAYS

PEDIATRICIAN TESTED

HIGH ENDURANCE VS. WATER

WATER RESISTANT

(80 MINUTES)

4 FL. OZ. (118 mL)

Stop Use and Ask A Doctor If

■ rash occurs.

Keep Out of Reach of Children.

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


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 aging caused by the sun.

Purpose

Sunscreen

Warnings

For external use only.

May stain some fabrics and surfaces.

Directions

■ Apply liberally 15 minutes before sun exposure ■ 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 this risk, regularly use 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 a.m. – 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor

Do Not Use (Do not use)

■ on damaged or broken skin.

Other Information

■protect the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 2.5%, Octocrylene 7.5%, Oxybenzone 3.5%

Inactive Ingredients:

Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate, Ethylhexyl Palmitate, Dimethicone, Hydrated Silica, Sodium Chloride, Phenoxyethanol, Beeswax, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Isohexadecane, Microcrystalline Wax, Polyethylene, Chlorphenesin, Caprylyl Glycol, Disodium EDTA, Stearoxy Dimethicone, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

When Using This Product (When using this product)

■ keep out of eyes. Rinse with water to remove.

Prinicipal Display Panel (PRINICIPAL DISPLAY PANEL)

BANANA

BOAT

KIDS

MAX PROTECT & PLAY

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 100

100

PROTECTS

FROM 99%

OF BURNING RAYS

PEDIATRICIAN TESTED

HIGH ENDURANCE VS. WATER

WATER RESISTANT

(80 MINUTES)

4 FL. OZ. (118 mL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)