Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 6b27a508-8669-418f-bcb2-61a35b79a3a8
Route
TOPICAL
Published
Effective Date 2017-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (2.5 g) Zinc Oxide
Inactive Ingredients
Water Isopropyl Palmitate Ethylhexyl Stearate Ethylhexyl Isononanoate Cetearyl Glucoside Dimethicone Phenoxyethanol Glycereth-26 Oleth-3 Phosphate Allantoin Triethoxycaprylylsilane Butylene Glycol Panthenol Ascorbyl Palmitate Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-31

Description

Octinoxate 7.5% Octisalate 2.5% Zinc Oxie 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5% Octisalate 2.5% Zinc Oxie 7.5%

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

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 docor if rash occurs



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

Directions

• apply generously 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• 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. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Octinoxate 7.5%

Octisalate 2.5%

Zinc Oxie 7.5%

Inactive Ingredients

Aqua/Water/Eau, Isopropyl Palmitate, Ethylhexyl Stearate, Ethylhexyl Isononanoate, Cyclopentasiloxane, Cetearyl Glucoside, Dimethicone, Phenoxyethanol, Glycereth-26, Oleth-3 Phosphate, Allantoin, Triethoxycaprylylsilane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Panthenol, Butylene Glycol, PEG-7 Trimethylolpropane Coconut Ether, Sodium Hyaluronate, Tocopheryl Acetate, Ascorbyl Palmitate, Iodopropynyl Butylcarbamate

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children


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

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 docor if rash occurs



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

Directions

• apply generously 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• 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. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Octinoxate 7.5%

Octisalate 2.5%

Zinc Oxie 7.5%

Inactive Ingredients (Inactive ingredients)

Aqua/Water/Eau, Isopropyl Palmitate, Ethylhexyl Stearate, Ethylhexyl Isononanoate, Cyclopentasiloxane, Cetearyl Glucoside, Dimethicone, Phenoxyethanol, Glycereth-26, Oleth-3 Phosphate, Allantoin, Triethoxycaprylylsilane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Panthenol, Butylene Glycol, PEG-7 Trimethylolpropane Coconut Ether, Sodium Hyaluronate, Tocopheryl Acetate, Ascorbyl Palmitate, Iodopropynyl Butylcarbamate

Principal Display Panel

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

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)