Sun Shield Body Glow Spf50

Sun Shield Body Glow Spf50
SPL v1
SPL
SPL Set ID 180aa4d5-6dac-e658-e063-6394a90a3287
Route
TOPICAL
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Homosalate (30 mg) Avobenzone (50 mg) Octisalate
Inactive Ingredients
Polyamide-3 (12000 Mw) Butyloctyl Salicylate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Titanium Dioxide .alpha.-tocopherol Acetate Ferric Oxide Red Benzyl Salicylate Linalool, (+/-)- Avocado Oil Macadamia Oil Octyldodecanol Mica Octyldodecyl Neopentanoate Hibiscus Sabdariffa Seed Oil Kukui Nut Oil Alkyl (c12-15) Benzoate .alpha.-hexylcinnamaldehyde Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-28

Description

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

Purpose

Homosalate 10%.........................................Sunscreen Octocrylene 10%.........................................Sunscreen Octisalate 5%..............................................Sunscreen Avobenzone 3%..........................................Sunscreen


Medication Information

Purpose

Homosalate 10%.........................................Sunscreen

Octocrylene 10%.........................................Sunscreen

Octisalate 5%..............................................Sunscreen

Avobenzone 3%..........................................Sunscreen

Description

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

Uses

• Helps prevent sunburn

• If used as directed with other sun protectionmeasures (see Directions), decreases the risk ofskin cancer and early skin aging caused by the sun

Section 50565-1

• Keep out of reach of children

• If product is swallowed, get medical help orcontact a Poison Control Center right away

Section 50566-9

• Stop use and ask a doctor if rash occurs

Section 50567-7

• When using this product keep out of eyes

• Rinse with water to remove

Section 50570-1

• Do not use on damaged or broken skin

Section 51945-4

Sun Shield Body Glow SPF 50

Broad Spectrum

UVA & UVB

40-Minute Sweat &

Water Resistant

& PABA-Free

Warnings

• For external use only

Directions

For Sunscreen use:

• Apply generously and evenly 15 minutes before sun exposure.

REAPPLY:

• After 40 minutes of swimming or sweating.Immediately after towel drying

• At least every 40 minutes

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.

• Children under 6 months: Ask doctor

Other Information

Protect the product in this container from excessive heat and direct sun

Active Ingredients

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Inactive Ingredients

Octyldodecanol, C12-15 Alkyl Benzoate, Polyamide-3, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Fragrance (Parfum), Persea Gratissima (Avocado) Oil, Hibiscus Sabdariffa Seed Oil, Cocos Nucifera (Coconut) Oil, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aleurites Moluccana Seed Oil, Tocopheryl Acetate, Macadamia Ternifolia Seed Oil, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Questions Or Comments?

Call (858) 252-0099


Structured Label Content

Uses

• Helps prevent sunburn

• If used as directed with other sun protectionmeasures (see Directions), decreases the risk ofskin cancer and early skin aging caused by the sun

Section 50565-1 (50565-1)

• Keep out of reach of children

• If product is swallowed, get medical help orcontact a Poison Control Center right away

Section 50566-9 (50566-9)

• Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

• When using this product keep out of eyes

• Rinse with water to remove

Section 50570-1 (50570-1)

• Do not use on damaged or broken skin

Section 51945-4 (51945-4)

Sun Shield Body Glow SPF 50

Broad Spectrum

UVA & UVB

40-Minute Sweat &

Water Resistant

& PABA-Free

Purpose

Homosalate 10%.........................................Sunscreen

Octocrylene 10%.........................................Sunscreen

Octisalate 5%..............................................Sunscreen

Avobenzone 3%..........................................Sunscreen

Warnings

• For external use only

Directions

For Sunscreen use:

• Apply generously and evenly 15 minutes before sun exposure.

REAPPLY:

• After 40 minutes of swimming or sweating.Immediately after towel drying

• At least every 40 minutes

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.

• Children under 6 months: Ask doctor

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun

Active Ingredients

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Inactive Ingredients (Inactive ingredients)

Octyldodecanol, C12-15 Alkyl Benzoate, Polyamide-3, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Fragrance (Parfum), Persea Gratissima (Avocado) Oil, Hibiscus Sabdariffa Seed Oil, Cocos Nucifera (Coconut) Oil, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aleurites Moluccana Seed Oil, Tocopheryl Acetate, Macadamia Ternifolia Seed Oil, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Questions Or Comments? (Questions or Comments?)

Call (858) 252-0099


Advanced Ingredient Data


Raw Label Data

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