equate tanning sunscreen uvb protection spf 15 spray dry oil

equate tanning sunscreen uvb protection spf 15 spray dry oil
SPL v3
SPL
SPL Set ID acdf62f2-742e-5df9-e053-2a95a90a96c5
Route
topical
Published
Effective Date 2020-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (100 mg) octisalate (50 mg) avobenzone (20 mg)
Inactive Ingredients
alcohol glycerin acrylate/isobutyl methacrylate/n-tert-octylacrylamide copolymer (75000 mw) light mineral oil tridecyl salicylate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-08-31

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%


Medication Information

Warnings

For external use only

FLAMMABLE:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

Uses

• helps prevent sunburn • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early signs of aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Purpose

Sunscreen

Directions

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away from the skin to apply

• Do not spray directly into face. Spray into hands then apply to face

• Do not apply in windy conditions

• Use in a well-ventilated area



• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months of age: Ask a doctor

Other Information

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

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

alcohol denat., tridecyl salicylate, acrylates/octylacrylamide copolymer, glycerin, mineral oil, fragrance.

Description

Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%

Label

Equate Tanning Sunscreen UVB Protection SPF 15 Spray Dry Oil

5.5 oz (156 g)

NDC 79903-007-37

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%

When Using This Product

• keep out of eyes. Rinse with water to remove. • Keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

Stop Use and Ask A Doctor If

• rash occurs.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

FLAMMABLE:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

Uses

• helps prevent sunburn • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early signs of aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Purpose

Sunscreen

Directions

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away from the skin to apply

• Do not spray directly into face. Spray into hands then apply to face

• Do not apply in windy conditions

• Use in a well-ventilated area



• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months of age: Ask a doctor

Other Information (Other information)

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

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients (Inactive ingredients)

alcohol denat., tridecyl salicylate, acrylates/octylacrylamide copolymer, glycerin, mineral oil, fragrance.

Label

Equate Tanning Sunscreen UVB Protection SPF 15 Spray Dry Oil

5.5 oz (156 g)

NDC 79903-007-37

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients (Active ingredients)

Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove. • Keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

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


Advanced Ingredient Data


Raw Label Data

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