smart care®

smart care®
SPL v1
SPL
SPL Set ID f1aa4a6b-3be5-4da8-93c0-f195c68da945
Route
topical
Published
Effective Date 2025-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (4.5 g) zinc oxide (6.5 g)
Inactive Ingredients
water homosalate octinoxate octocrylene glycerin isopropyl myristate cetyl peg/ppg-10/1 dimethicone (hlb 2) cetostearyl alcohol polyoxyl 20 cetostearyl ether butylene glycol medium-chain triglycerides dimethicone, unspecified glyceryl stearate se glyceryl stearate/peg-100 stearate cetyl palmitate isohexadecane phenoxyethanol lactic acid, unspecified form edetate disodium xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-13

Purpose

Sunscreen

Description

Titanium Dioxide 4.5% Zinc Oxide 6.5%


Medication Information

Warnings

For external use only

Do not use • on damaged or broken skin.

When using this product • keep out of eyes. Rinse with water to remove.

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

• apply liberally 15 minutes before sun exposure

• 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

Other Information

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

WATER, HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, GLYCERIN, ISOPROPYL MYRISTATE, CETYL PEG/PPG-10/1 DIMETHICONE, CETOSTEARYL ALCOHOL (AND) CETEARETH 20, BUTYLENE GLYCOL, CAPRYLIC CAPRIC TRIGLYCERIDE, DIMETHICONE, CETOSTEARYL ALCOHOL, GLYCERYL MONOSTEARATE SE, GLYCERYL STEARATE/PEG-100 STEARATE, CETYL PALMITATE, ISOHEXADECANE, PHENOXYETHANOL, LACTIC ACID, DISODIUM EDTA, XANTHAN GUM

Description

Titanium Dioxide 4.5% Zinc Oxide 6.5%

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.

Packaging

Drug Facts

Active Ingredients

Titanium Dioxide 4.5%

Zinc Oxide 6.5%

Questions Or Comments?

Call toll free 1-877-274-8358


Structured Label Content

Warnings

For external use only

Do not use • on damaged or broken skin.

When using this product • keep out of eyes. Rinse with water to remove.

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

• apply liberally 15 minutes before sun exposure

• 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

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)

WATER, HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, GLYCERIN, ISOPROPYL MYRISTATE, CETYL PEG/PPG-10/1 DIMETHICONE, CETOSTEARYL ALCOHOL (AND) CETEARETH 20, BUTYLENE GLYCOL, CAPRYLIC CAPRIC TRIGLYCERIDE, DIMETHICONE, CETOSTEARYL ALCOHOL, GLYCERYL MONOSTEARATE SE, GLYCERYL STEARATE/PEG-100 STEARATE, CETYL PALMITATE, ISOHEXADECANE, PHENOXYETHANOL, LACTIC ACID, DISODIUM EDTA, XANTHAN GUM

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.

Packaging

Drug Facts

Active Ingredients (Active ingredients)

Titanium Dioxide 4.5%

Zinc Oxide 6.5%

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358


Advanced Ingredient Data


Raw Label Data

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