Absolutely

Absolutely
SPL v2
SPL
SPL Set ID a26217cf-22ab-4c39-980a-b73467e16b91
Route
TOPICAL
Published
Effective Date 2023-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (8 g)
Inactive Ingredients
Aloe Vera Leaf Medium-chain Triglycerides Polyhydroxystearic Acid (2300 Mw) Water Ethylhexyl Oleate Squalane Isoamyl Laurate Lauryl Laurate Sorbitan Olivate Silicon Dioxide Carnauba Wax Rice Bran C13-15 Alkane Disteardimonium Hectorite Polyglyceryl-3 Pentaricinoleate Hydrogenated Rapeseed Oil Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Propanediol Watermelon Seed Oil Shea Butter Rosa Canina Fruit Oil Coconut Oil Sunflower Oil Green Tea Leaf Rosemary Helianthus Annuus Flowering Top Tocopherol Phytate Sodium Phenoxyethanol Ethylhexylglycerin Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-17

Description

Zinc Oxide 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 8%

Uses

Helps prevent sunburn.

Section 42229-5

EST.1992

Sheer Finish

Mineral Sunscreen

Vegan

REEF SAFE

Manufactured by: Absolutely Natural

640 Atlantis Road , Melbourne, FL 32904

absolutely-natural.com

cruelty free

MADE IN USA

Section 50565-1

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

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 doctor if rash occurs.

Packaging

Directions

• Apply liberally and evenly 15 minutes prior to sun exposure.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating

• Children under 6 months of age: Ask a doctor.

Drug Facts

​questions?

Call us! 800-848-7623

Active Ingredient

Zinc Oxide 8%

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aloe barbadensis leaf juice, caprylic/capric triglyceride, polyhydroxystearic acid, water, ethylhexyl olivate, squalane, isoamyl laurate, lauryl laurate, sorbitan olivate, silica, copernicia cerifera (carnauba) wax, oryza sativa (rice) bran wax, c13-15 alkane, disteardimonium hectorite, polyglyceryl-3 polyricinoleate, hydrogenated rapeseed oil, capryloyl glycerin/sebacic acid copolymer, propanediol, citrullus lanatus (watermelon) seed oil, butyrospermum parkii (shea) butter, rosa canina fruit oil, cocos nucifera (coconut) oil, helianthus annuus (sunflower) seed oil, camellia sinensis leaf extract, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol, sodium phytate, phenoxyethanol, ethylhexylglycerin, sodium chloride, fragrance.


Structured Label Content

Uses

Helps prevent sunburn.

Section 42229-5 (42229-5)

EST.1992

Sheer Finish

Mineral Sunscreen

Vegan

REEF SAFE

Manufactured by: Absolutely Natural

640 Atlantis Road , Melbourne, FL 32904

absolutely-natural.com

cruelty free

MADE IN USA

Section 50565-1 (50565-1)

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

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 doctor if rash occurs.

Packaging

Directions

• Apply liberally and evenly 15 minutes prior to sun exposure.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating

• Children under 6 months of age: Ask a doctor.

Drug Facts

​questions? (​Questions?)

Call us! 800-848-7623

Active Ingredient (Active ingredient)

Zinc Oxide 8%

Other Information (Other information)

• Protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf juice, caprylic/capric triglyceride, polyhydroxystearic acid, water, ethylhexyl olivate, squalane, isoamyl laurate, lauryl laurate, sorbitan olivate, silica, copernicia cerifera (carnauba) wax, oryza sativa (rice) bran wax, c13-15 alkane, disteardimonium hectorite, polyglyceryl-3 polyricinoleate, hydrogenated rapeseed oil, capryloyl glycerin/sebacic acid copolymer, propanediol, citrullus lanatus (watermelon) seed oil, butyrospermum parkii (shea) butter, rosa canina fruit oil, cocos nucifera (coconut) oil, helianthus annuus (sunflower) seed oil, camellia sinensis leaf extract, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol, sodium phytate, phenoxyethanol, ethylhexylglycerin, sodium chloride, fragrance.


Advanced Ingredient Data


Raw Label Data

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