Naked

Naked
SPL v1
SPL
SPL Set ID 65f1570a-6156-40e6-a792-e0707607dc2f
Route
TOPICAL
Published
Effective Date 2025-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (18 g)
Inactive Ingredients
Aloe Vera Leaf Juice Medium-chain Triglycerides Polyhydroxystearic Acid (2300 Mw) Water Ethylhexyl Olivate 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 East Indian Lemongrass Oil Tocopherol Phytate Sodium Phenoxyethanol Ethylhexylglycerin Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-29

Description

Zinc Oxide 18%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18%

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

Made for people. Turtle approved.TM

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

Reef Friendly

VEGAN  crueltyfree   MADE IN USA

Distributed by: 

Naked Turtle

7652 Ashley Park Ct.


#306, Orlando, FL 32835

WWW.NAKEDTURTLESUNSCREEN.CO

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! (407) 299-7333

Active Ingredient

Zinc Oxide 18%

Other Information

• Protect his 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, cymbopogon flexuosus oil, tocopherol, sodium phytate, phenoxyethanol, ethylhexylglycerin, sodium chloride, fragrance.


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)

Made for people. Turtle approved.TM

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

Reef Friendly

VEGAN  crueltyfree   MADE IN USA

Distributed by: 

Naked Turtle

7652 Ashley Park Ct.


#306, Orlando, FL 32835

WWW.NAKEDTURTLESUNSCREEN.CO

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! (407) 299-7333

Active Ingredient (Active ingredient)

Zinc Oxide 18%

Other Information (Other information)

• Protect his 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, cymbopogon flexuosus oil, tocopherol, sodium phytate, phenoxyethanol, ethylhexylglycerin, sodium chloride, fragrance.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)