smart care®

smart care®
SPL v2
SPL
SPL Set ID 1f91ba30-87b2-4bc9-bf1f-ca61ec355eb0
Route
topical
Published
Effective Date 2025-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2.7 g) homosalate (9 g) ethylhexyl salicylate (4.5 g) octocrylene (6 g)
Inactive Ingredients
butane propane isobutane alcohol alkyl (c12-15) benzoate butyloctyl salicylate isododecane copovidone k25-31 medium-chain triglycerides .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-24

Purpose

Sunscreen

Description

Avobenzone 2.7%  Homosalate 9.0% Octisalate 4.5% Octocrylene 6.0%


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)

Do not use • on damaged or broken skin.

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.

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

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 the face. Spray into hands then apply to the 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 doctor

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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. to 2 p.m. • wear long‑sleeve shirts, pants, hats, and sunglasses

Other Information

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

Butane, Propane, Isobutane, Alcohol Denat., C12‑15 Alkyl Benzoate, Butyloctyl Salicylate, Isododecane, Fragrance, VP/VA Copolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate

Description

Avobenzone 2.7%  Homosalate 9.0% Octisalate 4.5% Octocrylene 6.0%

Section 42229-5

UVA/UVB Protection

BROAD SPECTRUM

Water Resistant (80 Minutes)

Smart Care®

WWW.SMARTCAREUS.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CA 91761

DESIGNED IN U.S.A

MADE IN INDIA

Section 50565-1

Keep out of reach of children. If swallowed, call Poison Help at 1-800-222-1222 or go to PoisonHelp.org

Packaging

Drug Facts

Active Ingredients

Avobenzone 2.7% 

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 6.0%

Questions Or Comments?

Call toll free 1‑877‑274‑8358


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)

Do not use • on damaged or broken skin.

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.

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

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 the face. Spray into hands then apply to the 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 doctor

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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. to 2 p.m. • wear long‑sleeve shirts, pants, hats, and sunglasses

Other Information (Other information)

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients (Inactive ingredients)

Butane, Propane, Isobutane, Alcohol Denat., C12‑15 Alkyl Benzoate, Butyloctyl Salicylate, Isododecane, Fragrance, VP/VA Copolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate

Section 42229-5 (42229-5)

UVA/UVB Protection

BROAD SPECTRUM

Water Resistant (80 Minutes)

Smart Care®

WWW.SMARTCAREUS.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CA 91761

DESIGNED IN U.S.A

MADE IN INDIA

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, call Poison Help at 1-800-222-1222 or go to PoisonHelp.org

Packaging

Drug Facts

Active Ingredients (Active ingredients)

Avobenzone 2.7% 

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 6.0%

Questions Or Comments? (Questions or comments?)

Call toll free 1‑877‑274‑8358


Advanced Ingredient Data


Raw Label Data

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