Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID a1e14135-b8da-4cee-8c5b-1893572f4de4
Route
TOPICAL
Published
Effective Date 2022-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (5 g) Oxybenzone (3 g)
Inactive Ingredients
Water Octyldodecyl Neopentanoate Glycerin Glyceryl Monostearate Peg-100 Stearate Dimethicone Trolamine Diazolidinyl Urea Methylparaben Ethylparaben Propylparaben Levomenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-10-07

Description

Octinoxate 7.5% Octisalate 5% Oxybenzone 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5% Octisalate 5% Oxybenzone 3%

Use

■ helps prevent sunburn.

Warnings

Skin Cancer/Skin Aging Alert:Spending

time in the sun increases your risk of skin

cancer and early skin aging. This product has

been shown only to help prevent sunburn, not

skin cancer or early skin aging.

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

■ apply generously and evenly 15 minutes

    before sun exposure

■ apply to all skin exposed to the sun

■ use a water resistant sunscreen if

    swimming or sweating

■ reapply at least every 2 hours

■ children under 6 months of age:

   Ask a doctor

Other Information

■ protect this product from excessive heat

    and direct sun

■ may stain or damage some fabrics

    or surfaces

Active Ingredients

Octinoxate 7.5%

Octisalate 5%

Oxybenzone 3%

Inactive Ingredients

water, octyldodecyl neopentanoate, glycerin,

emulsifying wax NF, glyceryl stearate,

PEG-100 stearate, dimethicone,

triethanolamine, diazolidinyl urea, carbomer,

methylparaben, ethylparaben, propylparaben,

bisabolol, farnesol, citric acid

Questions Or Comments?

Call 1-800-553-5340

Principal Display Panel

PURPOSE ®

Dual

Treatment

Moisture

Lotion

Sunscreen

SPF 10

Oil-Free



Fragrance Free



Provides

Long-Lasting

Moisture



Developed with

Dermatologists



4 OZ (113g)

9474702

Keep Out of Reach of Children.

If product is

swallowed, get medical help or contact a

Poison Control Center right away.


Structured Label Content

Use

■ helps prevent sunburn.

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert:Spending

time in the sun increases your risk of skin

cancer and early skin aging. This product has

been shown only to help prevent sunburn, not

skin cancer or early skin aging.

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

■ apply generously and evenly 15 minutes

    before sun exposure

■ apply to all skin exposed to the sun

■ use a water resistant sunscreen if

    swimming or sweating

■ reapply at least every 2 hours

■ children under 6 months of age:

   Ask a doctor

Other Information (Other information)

■ protect this product from excessive heat

    and direct sun

■ may stain or damage some fabrics

    or surfaces

Active Ingredients (Active ingredients)

Octinoxate 7.5%

Octisalate 5%

Oxybenzone 3%

Inactive Ingredients (Inactive ingredients)

water, octyldodecyl neopentanoate, glycerin,

emulsifying wax NF, glyceryl stearate,

PEG-100 stearate, dimethicone,

triethanolamine, diazolidinyl urea, carbomer,

methylparaben, ethylparaben, propylparaben,

bisabolol, farnesol, citric acid

Questions Or Comments? (Questions or comments?)

Call 1-800-553-5340

Principal Display Panel

PURPOSE ®

Dual

Treatment

Moisture

Lotion

Sunscreen

SPF 10

Oil-Free



Fragrance Free



Provides

Long-Lasting

Moisture



Developed with

Dermatologists



4 OZ (113g)

9474702

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)