d7d2bca6-5000-4cb9-b004-b1ae286f6035

SPL v6
SPL
SPL Set ID d7d2bca6-5000-4cb9-b004-b1ae286f6035
Route
topical
Published
Effective Date 2025-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (0.19 g)
Inactive Ingredients
aloe barbadensis leaf juice caprylic/capric triglyceride coco-caprylate/caprate curcuma longa (turmeric) root water diisostearoyl polyglyceryl-3 dimer dilinoleate ethyl lauroyl arginate hydrochloride opuntia ficus-indica seed oil isoamyl laurate hydrolyzed jojoba esters mica tocopherol squalene polyglyceryl-3 oleate polyhydroxystearic acid (2300 mw) prickly pear fruit propanediol silica sodium chloride sodium stearoyl glutamate tetrasodium glutamate diacetate glycerin xanthan gum cocos nucifera (coconut) oil titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-30
Purpose

Sunscreen

Description

On damaged or broken skin.

Medication Information

Purpose

Sunscreen

Directions
  • Apply liberally 15 mins before aun exposure.
  • Reapply after 80 mins of swimming or sweating or immediately after towel drying and at least evary 2 hrs.
  • For children under 6 months of age; ask doctor.
Description

On damaged or broken skin.

Uses:



Helps prevent sunburn.

Section 50566-9



if rash occurs.

Section 51945-4

Purpose:

Sunscreen

Warnings:



For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

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

Do Not Use

On damaged or broken skin.

Other Info

Protect product from excessive heat and sun.

Directions:



- Apply liberally 15 minutes before sun exposure.

- Reapply:

- After 80 minutes of swimming or sweating

- Immediately after towel drying

- At least every 2 hours

- For children under 6 months of age: ask a doctor.

Inactive Ingredients:



Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Glycerin*, Butyloctyl Salicylate, Isopropyl Lauroyl Sarcosinate, Lauryl Glucoside, Polyglyceryl-3 Caprate, Polyhydroxystearic Acid, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Magnesium Sulfate, Cetearyl Alcohol, Polyglyceryl-10 Oleate, Polyhydroxystearic Acid, Stearalkonium Hectorite, Sodium Chloride, Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil*, Opuntia Ficus-Indica (Prickly Pear) Extract*, Macrocystis Pyrifera (Kelp) Extract*, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis (Green Tea) Extract*, Euterpe Oleracea (Acai) Fruit Extract*, Cucurbita Pepo (Pumpkin) Seed Extract*, Sodium Dehydroacetate, Ethylhexylglycerin, Sodium Gluconate, Citric Acid, Sodium Citrate, Potassium Sorbate, Sodium Benzoate, Fragrance**, Iron Oxide (CI 77491), Mica, Titanium Dioxide

*Organic Ingredients

Keep Out of Reach of Children.

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

Structured Label Content

Directions
  • Apply liberally 15 mins before aun exposure.
  • Reapply after 80 mins of swimming or sweating or immediately after towel drying and at least evary 2 hrs.
  • For children under 6 months of age; ask doctor.
Uses:



Helps prevent sunburn.

Section 50566-9 (50566-9)



if rash occurs.

Section 51945-4 (51945-4)

Purpose:

Sunscreen

Warnings:



For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

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

Do Not Use (Do not Use)

On damaged or broken skin.

Other Info

Protect product from excessive heat and sun.

Directions:



- Apply liberally 15 minutes before sun exposure.

- Reapply:

- After 80 minutes of swimming or sweating

- Immediately after towel drying

- At least every 2 hours

- For children under 6 months of age: ask a doctor.

Inactive Ingredients:



Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Glycerin*, Butyloctyl Salicylate, Isopropyl Lauroyl Sarcosinate, Lauryl Glucoside, Polyglyceryl-3 Caprate, Polyhydroxystearic Acid, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Magnesium Sulfate, Cetearyl Alcohol, Polyglyceryl-10 Oleate, Polyhydroxystearic Acid, Stearalkonium Hectorite, Sodium Chloride, Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil*, Opuntia Ficus-Indica (Prickly Pear) Extract*, Macrocystis Pyrifera (Kelp) Extract*, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis (Green Tea) Extract*, Euterpe Oleracea (Acai) Fruit Extract*, Cucurbita Pepo (Pumpkin) Seed Extract*, Sodium Dehydroacetate, Ethylhexylglycerin, Sodium Gluconate, Citric Acid, Sodium Citrate, Potassium Sorbate, Sodium Benzoate, Fragrance**, Iron Oxide (CI 77491), Mica, Titanium Dioxide

*Organic Ingredients

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:13.236255 · Updated: 2026-03-14T23:08:52.632356