SPL v2
SPL
SPL Set ID 312a32a7-d253-f10c-e063-6294a90a803a
Route
TOPICAL
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (142.8 mg)
Inactive Ingredients
Water Niacinamide Butyloctyl Salicylate Propanediol Squalane Aloe Vera Leaf 1,2-hexanediol Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Cetyl Alcohol Glycol Stearate Hydroxyacetophenone Glycerin Helianthus Annuus Whole Glyceryl Stearate Se Lecithin, Soybean Isostearic Acid Polyglyceryl-3 Pentaricinoleate Polyhydroxystearic Acid (2300 Mw) Vaccinium Vitis-idaea Fruit Oil Isohexadecane Xanthan Gum Polysorbate 80 Peg-6 Sorbitan Oleate Phenoxyethanol Jojoba Oil Citric Acid Acetate Gluconolactone Aluminum Sodium Benzoate Potassium Sorbate Silicon Calcium Gluconate Titanium Dioxide Brown Iron Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-25

Description

Zinc Oxide 14.2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 14.2%

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

Topical

Topical

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

Zinc Oxide 14.2%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Niacinamide, Butyloctyl Salicylate, Propanediol, Squalene, Aloe Barbadensis Leaf Juice, Sodium Acrylate/Sodium Acyloyldimethyl Tauarate Copolymer, 1,2-Hexanediol, Cetyl Alcohol, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyacetophenone, Polyisobutene, Glycerin, Glyceryl Stearate, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Vaccinium Vitis-Idaea Fruit Extract, Xanthan Gum, Caprylyl/Capryl Glucoside, Sorbitan Oleate, Phenoxyethanol, Jojoba Esters, Citric Acid, Gluconolactone, Plankotn Extract, Alumina, Sodium Benzoate, Potassium Sorbate, Silica, Calcium Glucate. May Contain (+/-): Titanium Dioxide (CI77891), Iron Oxides (CI 774941, 77492, 77499)

Questions Or Comments?

Call our Sunshine Concierge: 855-744-6366 (855-Shine-On)

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

Topical

Topical

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

Zinc Oxide 14.2%

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Niacinamide, Butyloctyl Salicylate, Propanediol, Squalene, Aloe Barbadensis Leaf Juice, Sodium Acrylate/Sodium Acyloyldimethyl Tauarate Copolymer, 1,2-Hexanediol, Cetyl Alcohol, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyacetophenone, Polyisobutene, Glycerin, Glyceryl Stearate, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Vaccinium Vitis-Idaea Fruit Extract, Xanthan Gum, Caprylyl/Capryl Glucoside, Sorbitan Oleate, Phenoxyethanol, Jojoba Esters, Citric Acid, Gluconolactone, Plankotn Extract, Alumina, Sodium Benzoate, Potassium Sorbate, Silica, Calcium Glucate. May Contain (+/-): Titanium Dioxide (CI77891), Iron Oxides (CI 774941, 77492, 77499)

Questions Or Comments? (Questions or Comments?)

Call our Sunshine Concierge: 855-744-6366 (855-Shine-On)

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

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