83447-013

83447-013
SPL v1
SPL
SPL Set ID 4477964b-28f3-a371-e063-6294a90a4230
Route
CUTANEOUS
Published
Effective Date 2025-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (8.75 g) Titanium Dioxide (2.55 g) Ethylhexyl Methoxycinnamate (3.996 g) Octocrylene (8 g)
Inactive Ingredients
Water Bisabolol Salmon, Unspecified Hydroxyacetophenone Alpha-tocopherol Acetate Glycerin Helianthus Annuus (sunflower) Seed Oil Peg/ppg-17/6 Copolymer Dimethicone 1,2-hexanediol C12-15 Alkyl Benzoate Butyrospermum Parkii (shea) Butter Magnesium Stearate Propylene Glycol Silica Squalane Triethoxycaprylylsilane Xanthan Gum Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Aluminum Hydroxide Phenyl Trimethicone Magnesium Sulfate Propanediol Parfumidine Panthenol Phenoxyethanol Bht

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-26

Description

Zinc Oxide 8.75% Octocrylene 8% Ethyhexyl Methoxycinnamate 3.996%. Titanium Dioxide (CI 77891)2.55%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 8.75% Octocrylene 8% Ethyhexyl Methoxycinnamate 3.996%. Titanium Dioxide (CI 77891)2.55%

Uses

Helps prevent sunburn



Section 51945-4

Stop Use

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

■Do not use on damaged or injured skin.

■Avoid contact with eyes.

■If it accidentally gets into your eyes, rinse immediately with plenty of water.

■Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away



Directions

■Apply liberally 15 minutes before sun exposure.

■Sun Protection Measures.

■Apply a generous layer of broad-spectrum SPF 30 sunscreen with antioxidant ingredients (e.g., salmon extract) 15 minutes

before sun exposure.

■Actively avoid the strong sunlight from 10 a.m. to 2 p.m.

■Wear long-sleeved clothes and trousers, protective hats and sunglasses when engaging in outdoor activities.

Infants under 6 months old should consult a doctor before use.

■Reapply sunscreen at least once every two

■hours.

When sweating while swimming, choose waterproof sunscreen products.

Do Not Use

Do not use on damaged or broken skin.

Keep Out Of

Keep out of reach of children

Other Information

Protect the product in this container from excessive heat and direct sun.



Active Ingredients

Zinc Oxide 8.75%

Octocrylene 8%

Ethyhexyl Methoxycinnamate 3.996%.

Titanium Dioxide (CI 77891)2.55%

Inactive Ingredients

Water, Glycerin, Propylene Glycol, C12-15 Alkyl Benzoate, Dimethicone, Cetyl

PEG/PPG-10/1 Dimethicone, Magnesium Stearate, PhenyI Trimethicone, TocopheryI

Acetate, PEG/PPG-17/6 Copolymer, Magnesium Sulfate, Propanediol, Panthenol, Phenoxyethanol,

Silica, Salmon Egg Extract, Xanthan Gum, Bisabolol, Helianthus Annuus (Sunflower)

Seed Oil, Butyrospermum Parkii (Shea) Butter, Aluminum Hydroxide, Squalane,

Triethoxycaprylylsilane, Parfum (Fragrance), 1,2-Hexanediol, p-Hydroxyacetophenone, BHT.

When Using This Product

When using this product, keep out of eyes.


Structured Label Content

Uses

Helps prevent sunburn



Section 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

■Do not use on damaged or injured skin.

■Avoid contact with eyes.

■If it accidentally gets into your eyes, rinse immediately with plenty of water.

■Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away



Directions

■Apply liberally 15 minutes before sun exposure.

■Sun Protection Measures.

■Apply a generous layer of broad-spectrum SPF 30 sunscreen with antioxidant ingredients (e.g., salmon extract) 15 minutes

before sun exposure.

■Actively avoid the strong sunlight from 10 a.m. to 2 p.m.

■Wear long-sleeved clothes and trousers, protective hats and sunglasses when engaging in outdoor activities.

Infants under 6 months old should consult a doctor before use.

■Reapply sunscreen at least once every two

■hours.

When sweating while swimming, choose waterproof sunscreen products.

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Keep Out Of (Keep out of)

Keep out of reach of children

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.



Active Ingredients (Active ingredients)

Zinc Oxide 8.75%

Octocrylene 8%

Ethyhexyl Methoxycinnamate 3.996%.

Titanium Dioxide (CI 77891)2.55%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, C12-15 Alkyl Benzoate, Dimethicone, Cetyl

PEG/PPG-10/1 Dimethicone, Magnesium Stearate, PhenyI Trimethicone, TocopheryI

Acetate, PEG/PPG-17/6 Copolymer, Magnesium Sulfate, Propanediol, Panthenol, Phenoxyethanol,

Silica, Salmon Egg Extract, Xanthan Gum, Bisabolol, Helianthus Annuus (Sunflower)

Seed Oil, Butyrospermum Parkii (Shea) Butter, Aluminum Hydroxide, Squalane,

Triethoxycaprylylsilane, Parfum (Fragrance), 1,2-Hexanediol, p-Hydroxyacetophenone, BHT.

When Using This Product (When using this product)

When using this product, keep out of eyes.


Advanced Ingredient Data


Raw Label Data

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