Smart Care®

Smart Care®
SPL v2
SPL
SPL Set ID 9398bad2-7270-4b6f-ab3a-21cb486377ec
Route
TOPICAL
Published
Effective Date 2025-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (19 g)
Inactive Ingredients
Water Mineral Oil White Wax White Petrolatum Microcrystalline Wax Sorbitan Sesquioleate Titanium Dioxide Dimethicone, Unspecified Peg-30 Dipolyhydroxystearate (4000 Mw) Calendula Officinalis Flower Magnesium Sulfate, Unspecified Form Phenoxyethanol Ethylhexylglycerin Citric Acid Monohydrate Magnesium Stearate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Aluminum Stearate Aloe Vera Leaf Juice

Identifiers & Packaging

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

Description

Zinc Oxide 19%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 19%

Section 42229-5

UVA/UVB PROTECTION

BROAD SPECTRUM

Water Resistant (80 Minutes)

DESIGNED IN U.S.A. • MADE IN INDIA

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

Section 50565-1

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

​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

Packaging

​purpose

Sunscreen

​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.

​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

​active Ingredients

Zinc Oxide 19%

​questions Or Comments?

Call toll free  ​1-877-274-8358

​ ​inactive Ingredients

Aqua (Water), Mineral Oil, Cera Alba (White Beeswax), White Petrolatum, Microcrystalline Wax, Sorbitan Sesquioleate, Titanium Dioxide, Dimethicone, PEG-30 Dipolyhydroxystearate, Calendula Officinalis Flower Oil, Magnesium Sulfate, Phenoxyethanol, Ethylhexylglycerin, Fragrance, Citric Acid, Magnesium Stearate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aluminium Stearate, Aloe Barbadensis Leaf Juice


Structured Label Content

Section 42229-5 (42229-5)

UVA/UVB PROTECTION

BROAD SPECTRUM

Water Resistant (80 Minutes)

DESIGNED IN U.S.A. • MADE IN INDIA

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

Section 50565-1 (50565-1)

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

​uses (​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

Packaging

​purpose (​Purpose)

Sunscreen

​warnings (​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.

​directions (​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

​active Ingredients (​Active ingredients)

Zinc Oxide 19%

​questions Or Comments? (​Questions or comments?)

Call toll free  ​1-877-274-8358

​ ​inactive Ingredients (​ ​Inactive ingredients)

Aqua (Water), Mineral Oil, Cera Alba (White Beeswax), White Petrolatum, Microcrystalline Wax, Sorbitan Sesquioleate, Titanium Dioxide, Dimethicone, PEG-30 Dipolyhydroxystearate, Calendula Officinalis Flower Oil, Magnesium Sulfate, Phenoxyethanol, Ethylhexylglycerin, Fragrance, Citric Acid, Magnesium Stearate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aluminium Stearate, Aloe Barbadensis Leaf Juice


Advanced Ingredient Data


Raw Label Data

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