Smart Care®

Smart Care®
SPL v1
SPL
SPL Set ID d810b762-9020-4028-a04b-187533a07676
Route
TOPICAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Ethylhexyl Salicylate (5 g) Octocrylene (6 g)
Inactive Ingredients
Butane Propane Isobutane Mineral Oil Ethylhexyl Palmitate Medium-chain Triglycerides Isododecane Cyclomethicone 5 Dimethicone, Unspecified Polyglyceryl-3 Diisostearate .alpha.-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-13

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 6.0%

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 42229-5

- UVA/UVB PROTECTION -

SHINE

Bright!

MALIBU

- CALIFORNIA -

WATER RESISTANT (80 MINUTES)

BROAD SPECTRUM

WWW.SMARTCAREUS.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CA 91761

barbie.com

BARBIE™ and associated trademarks and trade dress are owned by, and used under license from Mattel. ©2025 Mattel.

DESIGNED IN U.S.A.

MADE IN INDIA

Section 50565-1

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

Warnings

For external use only

Flammable:

• do not use near heat, flame or while smoking

• avoid long term storage above 104ºF (40ºC)

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 120ºF.

Stop use and ask a doctor if • rash occurs.

Packaging

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 a 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

Drug Facts

Other Information

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 6.0%

Inactive Ingredients

Butane, Propane, Isobutane, Mineral Oil, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Isododecane, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Fragrance, Tocopherol Acetate, Aloe Barbadensis Leaf Extract

Questions Or Comments?

Call toll free 1-877-274-8358


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 42229-5 (42229-5)

- UVA/UVB PROTECTION -

SHINE

Bright!

MALIBU

- CALIFORNIA -

WATER RESISTANT (80 MINUTES)

BROAD SPECTRUM

WWW.SMARTCAREUS.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CA 91761

barbie.com

BARBIE™ and associated trademarks and trade dress are owned by, and used under license from Mattel. ©2025 Mattel.

DESIGNED IN U.S.A.

MADE IN INDIA

Section 50565-1 (50565-1)

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

Purpose

Sunscreen

Warnings

For external use only

Flammable:

• do not use near heat, flame or while smoking

• avoid long term storage above 104ºF (40ºC)

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 120ºF.

Stop use and ask a doctor if • rash occurs.

Packaging

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 a 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

Drug Facts

Other Information (Other information)

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 6.0%

Inactive Ingredients (Inactive ingredients)

Butane, Propane, Isobutane, Mineral Oil, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Isododecane, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Fragrance, Tocopherol Acetate, Aloe Barbadensis Leaf Extract

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358


Advanced Ingredient Data


Raw Label Data

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