Absolutely 

Absolutely 
SPL v2
SPL
SPL Set ID 89657538-904d-4908-ba7b-6f84706a8001
Route
TOPICAL
Published
Effective Date 2023-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (19 g)
Inactive Ingredients
Coconut Oil Candelilla Wax Helianthus Annuus Seed Wax Olea Europaea (olive) Oil Unsaponifiables Toxicodendron Vernicifluum Fruit Rind Wax Shorea Robusta Resin Lauryl Laurate Polyhydroxystearic Acid (2300 Mw) Cocoa Butter Medium-chain Triglycerides Carnauba Wax Calcium Silicate Argan Oil .alpha.-tocopherol Acetate Levomenol Shea Butter Glyceryl Monocaprylate Glyceryl 1-undecylenate Orange Peel Wax Rice Bran Rosemary Helianthus Annuus Flowering Top Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-22

Description

Zinc Oxide 19%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 19%

Uses

• Helps prevent sunburn.

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Section 42229-5

EST. 1992

Mineral Sunscreen

Water Resistant (80 Minutes)

Vegan

MINERAL FACE & BODY STICK helps prevent sunburn and is infused with nutrients to help keep your skin nourished while in the sun.

√ Reef Safe

√ Sensitive Skin

√ Fragrance Free

√ Biodegradable

√ No Harsh Chemicals

Crueltyfree

MADE IN USA

Manufactured by: Absolutely Natural 640 Atlantis Road, Melbourne, FL 32904

www. Absolutely-Natural.com

Section 50565-1

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

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 doctor if rash occurs.

Packaging

Directions

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

• Reapply after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.

• 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.

Drug Facts

Questions?

Call us! 800-848-7623

Active Ingredient

Zinc Oxide 19%

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed wax, olea europaea (olive) oil unsaponifiables, rhus verniciflua peel wax, shorea robusta resin, lauryl laurate, polyhydroxystearic acid, theobroma cacao (cocoa) seed butter, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax, calcium silicate, argania spinosa kernel oil, tocopheryl acetate, bisabolol, butyrospermum parkii (shea) butter, glyceryl caprylate, glyceryl undecylenate, citrus aurantium dulcis peel wax, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol.


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 aging caused by the sun.

Section 42229-5 (42229-5)

EST. 1992

Mineral Sunscreen

Water Resistant (80 Minutes)

Vegan

MINERAL FACE & BODY STICK helps prevent sunburn and is infused with nutrients to help keep your skin nourished while in the sun.

√ Reef Safe

√ Sensitive Skin

√ Fragrance Free

√ Biodegradable

√ No Harsh Chemicals

Crueltyfree

MADE IN USA

Manufactured by: Absolutely Natural 640 Atlantis Road, Melbourne, FL 32904

www. Absolutely-Natural.com

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

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 after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.

• 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.

Drug Facts

Questions?

Call us! 800-848-7623

Active Ingredient (Active ingredient)

Zinc Oxide 19%

Other Information (Other information)

• Protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed wax, olea europaea (olive) oil unsaponifiables, rhus verniciflua peel wax, shorea robusta resin, lauryl laurate, polyhydroxystearic acid, theobroma cacao (cocoa) seed butter, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax, calcium silicate, argania spinosa kernel oil, tocopheryl acetate, bisabolol, butyrospermum parkii (shea) butter, glyceryl caprylate, glyceryl undecylenate, citrus aurantium dulcis peel wax, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol.


Advanced Ingredient Data


Raw Label Data

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