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

Purpose

purpose: sunscreen

Description

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


Medication Information

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 .

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

Purpose

purpose: sunscreen

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 .

Other Information



Other information

protect this product from excessive heat and direct sun

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

Description

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

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 .

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

Active Ingredients

Avobenzone 3%

Homosalate 5%

0ctisalate 5%

0ctocrylene 10%

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

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 .

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

Purpose

purpose: sunscreen

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 .

Other Information



Other information

protect this product from excessive heat and direct sun

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

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

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 .

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

Active Ingredients

Avobenzone 3%

Homosalate 5%

0ctisalate 5%

0ctocrylene 10%

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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