Smart Care®

Smart Care®
SPL v2
SPL
SPL Set ID d68048b5-219c-414a-918f-b063b44fe7b5
Route
TOPICAL
Published
Effective Date 2025-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9 g) Ethylhexyl Salicylate (3 g) Octocrylene (6 g) Zinc Oxide (7.3 g)
Inactive Ingredients
Butane Isobutane Propane Water Isododecane Butyloctyl Salicylate Medium-chain Triglycerides Propylene Glycol Phenoxyethanol Stearic Acid Polyglyceryl-10 Myristate Dimethicone Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-24

Description

Homosalate 9.0% Octisalate 3.0% Octocrylene 6.0% Zinc Oxide 7.3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 9.0% Octisalate 3.0% Octocrylene 6.0% Zinc Oxide 7.3%

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

BROAD SPECTRUM

Water Resistant (80 Minutes)

DESIGNED IN U.S.A.

MADE IN INDIA

SmartCare®

WWW.SMARTCAREUS.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CA 91761

Section 50565-1

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

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.

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

Homosalate 9.0%

Octisalate 3.0%

Octocrylene 6.0%

Zinc Oxide 7.3%

Inactive Ingredients

Butane, Isobutane, Propane, Aqua (Water), Isododecane, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Propylene Glycol, Phenoxyethanol, Stearic Acid, Polyglyceryl-10 Myristate, Dimethicone, Triethanolamine

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

BROAD SPECTRUM

Water Resistant (80 Minutes)

DESIGNED IN U.S.A.

MADE IN INDIA

SmartCare®

WWW.SMARTCAREUS.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CA 91761

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 

Purpose

Sunscreen

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.

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)

Homosalate 9.0%

Octisalate 3.0%

Octocrylene 6.0%

Zinc Oxide 7.3%

Inactive Ingredients (Inactive ingredients)

Butane, Isobutane, Propane, Aqua (Water), Isododecane, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Propylene Glycol, Phenoxyethanol, Stearic Acid, Polyglyceryl-10 Myristate, Dimethicone, Triethanolamine

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358


Advanced Ingredient Data


Raw Label Data

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