naked sundays face + body clear glow sunstick spf50 shimmer broad spectrum spf50 19g

naked sundays face + body clear glow sunstick spf50 shimmer broad spectrum spf50 19g
SPL v2
SPL
SPL Set ID 2f47a6c9-dd0a-da94-e063-6294a90a9a45
Route
topical
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (5 g) avobenzone (3 g) octocrylene (8 g) homosalate (10 g)
Inactive Ingredients
glycine soja (soybean) oil dicaprylyl carbonate fd&c yellow no. 6 aluminum lake aloe barbadensis leaf titanium dioxide ceresin persea gratissima (avocado) oil mica caprylic/capric triglyceride butyloctyl salicylate polyethylene brown iron oxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-01

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 8%


Medication Information

Warnings and Precautions

Warnings: For external use only. Do not use on

damaged or broken skin. Avoid prolonged sun

exposure. When using this product: Keep out of

eyes. Rinse with water to remove. Keep out of reach

of children. Stop use and ask a doctor if rashes

occur. If product is swallowed, get medical help or

contact a Poison Control Center right away.

Active Ingredient

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

Indications and Usage

Use: Helps prevent sunburn. If used as directed

with other sun protection measures (see

Directions), decreases the risk of skin cancer and

early skin ageing caused by the sun

Dosage and Administration

Directions: Apply liberally and evenly 15 minutes

before sun exposure. Reapply at least every 2

hours or immediately after swimming, sweating or

towel drying. Use a water-resistant sunscreen if

swimming or sweating.

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 8%

Section 50565-1

Keep out of reach

of children. Stop use and ask a doctor if rashes

occur.

Section 51727-6

INACTIVE INGREDIENTS: Aloe Barbadensis Leaf Extract, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, FD&C Yellow 6 Lake (CI 15985:1), Glycine Soja (Soybean) Oil, Iron Oxides (CI 77491), Mica, Ozokerite, Persea Gratissima (Avocado) Oil, Polyethylene, Titanium Dioxide (CI 77891)

Section 51945-4

Section 53413-1

Questions: [email protected]

Section 55105-1

SUNSCREEN

Section 60561-8

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 10AM - 2PM

Wear long-sleeved shirts, pants, hats, and

sunglasses Children under 6 months of age: Ask a

doctor.


Structured Label Content

Warnings and Precautions (34071-1)

Warnings: For external use only. Do not use on

damaged or broken skin. Avoid prolonged sun

exposure. When using this product: Keep out of

eyes. Rinse with water to remove. Keep out of reach

of children. Stop use and ask a doctor if rashes

occur. If product is swallowed, get medical help or

contact a Poison Control Center right away.

Active Ingredient (55106-9)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

Indications and Usage (34067-9)

Use: Helps prevent sunburn. If used as directed

with other sun protection measures (see

Directions), decreases the risk of skin cancer and

early skin ageing caused by the sun

Dosage and Administration (34068-7)

Directions: Apply liberally and evenly 15 minutes

before sun exposure. Reapply at least every 2

hours or immediately after swimming, sweating or

towel drying. Use a water-resistant sunscreen if

swimming or sweating.

Section 50565-1 (50565-1)

Keep out of reach

of children. Stop use and ask a doctor if rashes

occur.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Aloe Barbadensis Leaf Extract, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, FD&C Yellow 6 Lake (CI 15985:1), Glycine Soja (Soybean) Oil, Iron Oxides (CI 77491), Mica, Ozokerite, Persea Gratissima (Avocado) Oil, Polyethylene, Titanium Dioxide (CI 77891)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions: [email protected]

Section 55105-1 (55105-1)

SUNSCREEN

Section 60561-8 (60561-8)

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 10AM - 2PM

Wear long-sleeved shirts, pants, hats, and

sunglasses Children under 6 months of age: Ask a

doctor.


Advanced Ingredient Data


Raw Label Data

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