84532-001_goodal green tangerine vita c dark spot uv defense sunscreen spf50

84532-001_goodal green tangerine vita c dark spot uv defense sunscreen spf50
SPL v1
SPL
SPL Set ID 77a0d190-f558-474b-89d2-c79b37c50c0d
Route
topical
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (95 mg) ethylhexyl salicylate (47.5 mg) octocrylene (90 mg) avobenzone (28.5 mg)
Inactive Ingredients
water tangerine butylene glycol propanediol ethylhexyl methoxycrylene silicon dioxide butyloctyl salicylate niacinamide pentylene glycol polyglyceryl-3 distearate 1,2-hexanediol arbutin potassium cetyl phosphate cetearyl olivate cetyl alcohol sorbitan olivate hydroxyacetophenone carbomer homopolymer, unspecified type tromethamine xanthan gum glyceryl stearate citrate glycerin ethylhexylglycerin n-acetylglucosamine hyaluronate sodium vincetoxicum atratum root alcea rosea flower caprylyl glycol allantoin ascorbic acid ascorbyl glucoside madecassoside panthenol tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-16

Description

Homosalate 9.50% Octocrylene 9.00% Octisalate 4.75% Avobenzone 2.85%


Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Active Ingredient

Homosalate 9.50%

Octocrylene 9.00%

Octisalate 4.75%

Avobenzone 2.85%

Indications and Usage

Helps prevent sunburn

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

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Reapply at least every two hours

Use a water-resistant sunscreen if swimming or sweating

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: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses

Description

Homosalate 9.50% Octocrylene 9.00% Octisalate 4.75% Avobenzone 2.85%

Section 50565-1

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

Section 51727-6

Water, Citrus Tangerina (Tangerine) Extract, Butylene Glycol, Propanediol, Ethylhexyl Methoxycrylene, Silica, Butyloctyl Salicylate, Niacinamide, Pentylene Glycol, Polyglyceryl-3 Distearate, 1,2-Hexanediol, Arbutin, Potassium Cetyl Phosphate, Cetearyl Olivate, Cetyl Alcohol, Sorbitan Olivate, Hydroxyacetophenone, Carbomer, Tromethamine, Xanthan Gum, Glyceryl Stearate Citrate, Glycerin, Ethylhexylglycerin, Acetyl Glucosamine, Sodium Hyaluronate, Cynanchum Atratum Extract, Sodium Hyaluronate Crosspolymer, Althaea Rosea Flower Extract, Caprylyl Glycol, Allantoin, Ascorbic Acid, Ascorbyl Glucoside, Madecassoside, Panthenol, Tocopherol

Section 51945-4

Section 55105-1

Sunscreen

Section 60561-8

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


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Active Ingredient (55106-9)

Homosalate 9.50%

Octocrylene 9.00%

Octisalate 4.75%

Avobenzone 2.85%

Indications and Usage (34067-9)

Helps prevent sunburn

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

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Reapply at least every two hours

Use a water-resistant sunscreen if swimming or sweating

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: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, Citrus Tangerina (Tangerine) Extract, Butylene Glycol, Propanediol, Ethylhexyl Methoxycrylene, Silica, Butyloctyl Salicylate, Niacinamide, Pentylene Glycol, Polyglyceryl-3 Distearate, 1,2-Hexanediol, Arbutin, Potassium Cetyl Phosphate, Cetearyl Olivate, Cetyl Alcohol, Sorbitan Olivate, Hydroxyacetophenone, Carbomer, Tromethamine, Xanthan Gum, Glyceryl Stearate Citrate, Glycerin, Ethylhexylglycerin, Acetyl Glucosamine, Sodium Hyaluronate, Cynanchum Atratum Extract, Sodium Hyaluronate Crosspolymer, Althaea Rosea Flower Extract, Caprylyl Glycol, Allantoin, Ascorbic Acid, Ascorbyl Glucoside, Madecassoside, Panthenol, Tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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