82723-005

82723-005
SPL v6
SPL
SPL Set ID 0ad0f69b-6bdc-05fa-e063-6294a90acaf9
Route
TOPICAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 mg) Homosalate (5 mg) Octisalate (10 mg) Octocrylene
Inactive Ingredients
Xylitol Hydroxyacetophenone Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Water Propylene Glycol Cetostearyl Alcohol Potassium Cetyl Phosphate Sodium Polyacrylate (8000 Mw) Ethylhexyl Stearate Trideceth-6 Ammonium Acryloyldimethyltaurate/vp Copolymer Phenoxyethanol 1,2-hexanediol Anhydroxylitol Maltodextrin Butylene Glycol Centella Asiatica Leaf Aloe Vera Leaf Glycerin Centella Asiatica Triterpenoids Inulin Lauryl Carbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-01

Description

Avobenzone 3% Homosalate 5% 0ctisalate 5% 0ctocrylene 10%

Purpose

purpose: sunscreen


Medication Information

Purpose

purpose: sunscreen

Description

Avobenzone 3% Homosalate 5% 0ctisalate 5% 0ctocrylene 10%

Uses

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun protection

measures ( see Directions ) , decreases the risk of skin

cancer and early skin aging caused by the sun

Section 50567-7



When using this product keep out of eyes , Rinse

with water to remove

Stop use and ask a doctor if rash occurs

Stop Use



When using this product keep out of eyes , Rinse

with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children . If swallowed , get

medical help or contact a Poison Control Center right

away .

Warnings



Warnings

For external use only .

y on damaged or broken skin

When using this product keep out of eyes , Rinse

with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children . If swallowed , get

medical help or contact a Poison Control Center right

away .

Directions



Directions

Apply liberally 15 minutes before sun exposure

Reapplly :

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 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-sleeve shirts , pants , hats , and sunglasses .

Do Not Use

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 a doctor if rash occurs

Keep out of reach of children . If swallowed , get medical

help or contact a Poison Control Center right away .

Package Label

82723-005 TATTOO ULTRA SUNSCREEN

Other Information



Other information

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3%

Homosalate 5%

0ctisalate 5%

0ctocrylene 10%

Inactive Ingredients



Inactive ingredients

Aqua, Propylene Glycol, Glycerin, Inulin Laury

Carbamate, Vinyl Dimethicone/Methicone

Silsesquioxane Crosspolymer, Cetearyl Alcohol,

Potassium Cetyl Phosphate, Sodium Polyacrylate,

Ethylhexyl Stearate, Trideceth-6, Ammonium

Acryloyldimethyltaurate/Vp Copolymer,

Phenoxyethanol, 1, 2-hexanediol

Hydroxyacetophenone, Maltodextrin, Centella

Asiatica Leaf Extract Aloe Barbadensis Leaf Water

Saccharomyces/ice Ferment Filtrate, Butylene

Glycol, Anhydroxylitol, Tremella Fuciformis

(Mushroom)Extract, Centella Asiatica Extract, Xylitol

Keep Out of Reach of Children.



Keep out of reach of children . If swallowed , get

medical help or contact a Poison Control Center right

away .


Structured Label Content

Uses

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun protection

measures ( see Directions ) , decreases the risk of skin

cancer and early skin aging caused by the sun

Section 50567-7 (50567-7)



When using this product keep out of eyes , Rinse

with water to remove

Stop use and ask a doctor if rash occurs

Purpose

purpose: sunscreen

Stop Use (Stop use)



When using this product keep out of eyes , Rinse

with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children . If swallowed , get

medical help or contact a Poison Control Center right

away .

Warnings



Warnings

For external use only .

y on damaged or broken skin

When using this product keep out of eyes , Rinse

with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children . If swallowed , get

medical help or contact a Poison Control Center right

away .

Directions



Directions

Apply liberally 15 minutes before sun exposure

Reapplly :

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 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-sleeve shirts , pants , hats , and sunglasses .

Do Not Use (Do not use)

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 a doctor if rash occurs

Keep out of reach of children . If swallowed , get medical

help or contact a Poison Control Center right away .

Package Label

82723-005 TATTOO ULTRA SUNSCREEN

Other Information



Other information

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3%

Homosalate 5%

0ctisalate 5%

0ctocrylene 10%

Inactive Ingredients



Inactive ingredients

Aqua, Propylene Glycol, Glycerin, Inulin Laury

Carbamate, Vinyl Dimethicone/Methicone

Silsesquioxane Crosspolymer, Cetearyl Alcohol,

Potassium Cetyl Phosphate, Sodium Polyacrylate,

Ethylhexyl Stearate, Trideceth-6, Ammonium

Acryloyldimethyltaurate/Vp Copolymer,

Phenoxyethanol, 1, 2-hexanediol

Hydroxyacetophenone, Maltodextrin, Centella

Asiatica Leaf Extract Aloe Barbadensis Leaf Water

Saccharomyces/ice Ferment Filtrate, Butylene

Glycol, Anhydroxylitol, Tremella Fuciformis

(Mushroom)Extract, Centella Asiatica Extract, Xylitol

Keep Out of Reach of Children. (Keep out of reach of children.)



Keep out of reach of children . If swallowed , get

medical help or contact a Poison Control Center right

away .


Advanced Ingredient Data


Raw Label Data

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