Smart Care®

Smart Care®
SPL v1
SPL
SPL Set ID 2a673856-655a-4547-af6d-273a52ff8814
Route
TOPICAL
Published
Effective Date 2025-02-13
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
Alcohol Butane Propane Isobutane Isododecane Alkyl (c12-15) Benzoate Butyloctyl Salicylate Copovidone K25-31 Medium-chain Triglycerides .alpha.-tocopherol Acetate

Identifiers & Packaging

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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7% Homosalate 9.0% Octisalate 4.5% 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

BROAD SPECTRUM

Water Resistant (80 Minutes)

DESIGNED IN U.S.A.

MADE IN INDIA

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, 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 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

Avobenzone 2.7%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 6.0%

Inactive Ingredients

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

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

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, 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 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)

Avobenzone 2.7%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 6.0%

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)