81540-102

81540-102
SPL v2
SPL
SPL Set ID 30bdb3c6-2bfa-87c2-e063-6394a90a9a43
Route
TOPICAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (8.94375 g)
Inactive Ingredients
Disteardimonium Hectorite 1,2-hexanediol Panthenol Polyglyceryl-2 Dipolyhydroxystearate Glyceryl Caprylate Melaleuca Alternifolia (tea Tree) Leaf Melaleuca Alternifolia Flowering Top Propanediol Polyglyceryl-6 Polyricinoleate Polymethylsilsesquioxane (4.5 Microns) Caprylic/capric Triglyceride Citrus Aurantium Bergamia (bergamot) Fruit Oil Centella Asiatica Triterpenoids Tocopherol Sodium Chloride Melaleuca Alternifolia (tea Tree) Leaf Oil Triethoxycaprylylsilane Propylheptyl Caprylate Chromium Oxide Greens Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Cetyl Ethylhexanoate Water Dicaprylyl Carbonate Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Butyloctyl Salicylate Isododecane Diphenylsiloxy Phenyl Trimethicone Niacinamide Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-20

Description

Zinc Oxide 17.8%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Dosage and Administration

■ apply liberally 15 minutes before sun exposure ■ 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. - 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating

Description

Zinc Oxide 17.8%

Section 50565-1

■ keep out of reach of children

Section 50566-9

Stop use and ask a doctor if ■ rash occurs

Section 50567-7

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

Section 50570-1

Do not use ■ on damaged or broken skin

Section 51727-6

Water, Butyloctyl Salicylate, Caprylic/ Capric Triglyceride, Isododecane, Propanediol, Propylheptyl Caprylate, Polyglyceryl-6 Polyricinoleate, Cetyl Ethylhexanoate, Diphenylsiloxy Phenyl Trimethicone, Niacinamide, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Sodium Chloride, Lauryl Polyglyceryl- 3 Polydimethylsiloxyethyl Dimethicon e, Polyglyceryl-4 Diisostearate/Polyhy- droxystearate/Sebacate, Disteardimonium Hectorite, 1,2-Hexanediol, Triethoxycaprylylsilane, Panthenol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Glyceryl Caprylate, Citrus Aurantium Bergamia (Bergam ot) Fruit Oil, Limonene, Linalool, Tocopherol, Centella Asiatica Extract, Melaleuca Alternifolia (Tea Tree) Extract, Mel aleuca Alternifolia (Tea Tree) Leaf Water, Melaleuca Alternifolia (Tea Tree) Le af Extract, Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chromium Oxide Greens (CI 77288)

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 17.8%

Section 60561-8

■ protect the product in this container from excessive heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

■ apply liberally 15 minutes before sun exposure ■ 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. - 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

■ keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask a doctor if ■ rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use ■ on damaged or broken skin

Section 51727-6 (51727-6)

Water, Butyloctyl Salicylate, Caprylic/ Capric Triglyceride, Isododecane, Propanediol, Propylheptyl Caprylate, Polyglyceryl-6 Polyricinoleate, Cetyl Ethylhexanoate, Diphenylsiloxy Phenyl Trimethicone, Niacinamide, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Sodium Chloride, Lauryl Polyglyceryl- 3 Polydimethylsiloxyethyl Dimethicon e, Polyglyceryl-4 Diisostearate/Polyhy- droxystearate/Sebacate, Disteardimonium Hectorite, 1,2-Hexanediol, Triethoxycaprylylsilane, Panthenol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Glyceryl Caprylate, Citrus Aurantium Bergamia (Bergam ot) Fruit Oil, Limonene, Linalool, Tocopherol, Centella Asiatica Extract, Melaleuca Alternifolia (Tea Tree) Extract, Mel aleuca Alternifolia (Tea Tree) Leaf Water, Melaleuca Alternifolia (Tea Tree) Le af Extract, Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chromium Oxide Greens (CI 77288)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 17.8%

Section 60561-8 (60561-8)

■ protect the product in this container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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