Anhydrous Spf 30 30g Tube 59958-200-03

Anhydrous Spf 30 30g Tube 59958-200-03
SPL v3
SPL
SPL Set ID 1510cae2-9c8f-45ba-b088-67747af3d30c
Route
TOPICAL
Published
Effective Date 2011-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (17.5 g) Zinc Oxide (1 g)
Inactive Ingredients
Cyclomethicone Tribehenin Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-03-01

Description

Active ingredients                  Purpose Titanium Dioxide 10.20%        Sunscreen Zinc Oxide 3.70%                  Sunscreen


Medication Information

Warnings and Precautions

Warnings

For external use only. When using this product

keep out of eyes.  Rinse with water to remove.

Stop use and ask doctor if rash and irritation

develops and lasts.  Keep out of reach of

children. If swallowed, get medical help or

contact poison control center right away.

Indications and Usage

Directions

Apply evenly before sun exposure and as

needed.  For children under 6 months of age: ask

a doctor.  Reapply as needed or after towel

drying, swimming or perspiring.

Description

Active ingredients                  Purpose Titanium Dioxide 10.20%        Sunscreen Zinc Oxide 3.70%                  Sunscreen

Section 34076-0

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other

harmful effects of the sun.

Section 51727-6

Inactive Ingredients

Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,

Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,

Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.

Section 51945-4

Section 55105-1

USES

Helps Prevent sunburn.

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

Drug Facts

Active ingredients                  Purpose

Titanium Dioxide 10.20%        Sunscreen

Zinc Oxide 3.70%                  Sunscreen

Dosage & Administration

- Apply liberally 15 minutes before sun exposure

- use a water resistant sunscreen if swimming or sweating

- reapply at least every 2 hours

- children under 6 months: Ask a doctor

Keep Out of Reach of Children

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


Structured Label Content

Indications and Usage (34067-9)

Directions

Apply evenly before sun exposure and as

needed.  For children under 6 months of age: ask

a doctor.  Reapply as needed or after towel

drying, swimming or perspiring.

Warnings and Precautions (34071-1)

Warnings

For external use only. When using this product

keep out of eyes.  Rinse with water to remove.

Stop use and ask doctor if rash and irritation

develops and lasts.  Keep out of reach of

children. If swallowed, get medical help or

contact poison control center right away.

Section 34076-0 (34076-0)

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other

harmful effects of the sun.

Section 51727-6 (51727-6)

Inactive Ingredients

Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,

Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,

Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

USES

Helps Prevent sunburn.

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

Drug Facts

Active ingredients                  Purpose

Titanium Dioxide 10.20%        Sunscreen

Zinc Oxide 3.70%                  Sunscreen

Dosage & Administration

- Apply liberally 15 minutes before sun exposure

- use a water resistant sunscreen if swimming or sweating

- reapply at least every 2 hours

- children under 6 months: Ask a doctor

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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