Dr.oracle Air Fit Defense Soothing Sunscreen

Dr.oracle Air Fit Defense Soothing Sunscreen
SPL v2
SPL
SPL Set ID 21424f78-f8d5-6a9b-e063-6294a90ab7dc
Route
TOPICAL
Published
Effective Date 2024-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (6.35 g) Octisalate (2.25 g) Titanium Dioxide (1.1 g) Homosalate (3.75 g)
Inactive Ingredients
Triethoxycaprylylsilane Aluminum Hydroxide Ethylhexylglycerin Sodium Citrate Cyclomethicone 5 Stearic Acid Sorbitan Monocaprylate Glyceryl Caprylate Cocoyl Caprylocaprate Glycerin Niacinamide Butyloctyl Salicylate Magnesium Sulfate, Unspecified Form 1,2-hexanediol Tocopherol Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Dimethicone/peg-10/15 Crosspolymer Water Dimethicone Dipropylene Glycol Disteardimonium Hectorite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-26

Description

Homosalate 7.5 % Octyl salicylate 4.5 % Titanium dioxide 2.2 % Zinc oxide 12.7 %

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

Homosalate 7.5 % Octyl salicylate 4.5 % Titanium dioxide 2.2 % Zinc oxide 12.7 %

Uses

• helps prevent sunburn • 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 51945-4

Warnings

For external use only

Directions

■ apply liberally 15 minutes before sun exposure. 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 of age: Ask a doctor

■ reapply at least every 2 hours

■ use a water-resistant sunscreen if swimming or sweating

Do Not Use

• on damaged skin or broken skin

Other Information

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredients

Homosalate 7.5 %

Octyl salicylate 4.5 %

Titanium dioxide 2.2 %

Zinc oxide 12.7 %

Inactive Ingredients

Water, Cyclopentasiloxane, Coco-Caprylate/Caprate, Dipropylene Glycol, Lauryl PEG-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Butyloctyl Salicylate, Methyl Methacrylate Crosspolymer, Dist- eardimonium Hectorite, Magnesium Sulfate, Vinyl Dimethicone/Methicone Silsesquioxane Cross- polymer, Dimethicone, 1,2-Hexanediol,Triethoxycaprylylsilane, Stearic Acid, Aluminum Hydroxide, Sorbitan Caprylate, Dimethicone/PEG- 10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Sodium Citrate, Tocopherol

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.


Structured Label Content

Uses

• helps prevent sunburn • 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 51945-4 (51945-4)

Purpose

sunscreen

Warnings

For external use only

Directions

■ apply liberally 15 minutes before sun exposure. 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 of age: Ask a doctor

■ reapply at least every 2 hours

■ use a water-resistant sunscreen if swimming or sweating

Do Not Use (Do not use)

• on damaged skin or broken skin

Other Information (Other information)

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredients (Active ingredients)

Homosalate 7.5 %

Octyl salicylate 4.5 %

Titanium dioxide 2.2 %

Zinc oxide 12.7 %

Inactive Ingredients (Inactive ingredients)

Water, Cyclopentasiloxane, Coco-Caprylate/Caprate, Dipropylene Glycol, Lauryl PEG-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Butyloctyl Salicylate, Methyl Methacrylate Crosspolymer, Dist- eardimonium Hectorite, Magnesium Sulfate, Vinyl Dimethicone/Methicone Silsesquioxane Cross- polymer, Dimethicone, 1,2-Hexanediol,Triethoxycaprylylsilane, Stearic Acid, Aluminum Hydroxide, Sorbitan Caprylate, Dimethicone/PEG- 10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Sodium Citrate, Tocopherol

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs

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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