Dolce & Gabbana Get Your Healthy Glowy Skin

Dolce & Gabbana Get Your Healthy Glowy Skin
SPL v2
SPL
SPL Set ID 91bf1cca-8d18-4c59-864d-4fd0619c6713
Route
TOPICAL
Published
Effective Date 2024-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (67 mg)
Inactive Ingredients
Water Dimethicone C12-15 Alkyl Benzoate Phenyl Trimethicone Talc Glycerin Isostearyl Neopentanoate Glyceryl Glucoside Bis-peg/ppg-14/14 Dimethicone Isododecane Phenoxyethanol Sodium Chloride Mica Magnesium Sulfate Menthoxypropanediol Sodium Dehydroacetate Triethoxycaprylylsilane Benzoic Acid Aluminum Hydroxide Dehydroacetic Acid Bilberry Propylene Carbonate Ethylhexylglycerin Laureth-4 Potassium Sorbate Sodium Benzoate Lactic Acid Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Octisalate 3.5% Octocrylene 5% Titanium dioxide 0.5% Zinc Oxide 1.88%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octisalate 3.5% Octocrylene 5% Titanium dioxide 0.5% Zinc Oxide 1.88%

Uses
  • Helps prevent sunburn
  • If uses directed with others sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings

For external use only.

Directions
  • Apply generously 15 minutes before sun exposure
  • Reapply at least every 2 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 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

SHAKE WELL BEFORE USE

Do Not Use

on damaged or broken skin.

Drug Facts

Other Information

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

Package Labeling:

Active Ingredients

Octisalate 3.5%

Octocrylene 5%

Titanium dioxide 0.5%

Zinc Oxide 1.88%

Inactive Ingredients

WATER/EAU (AQUA), DIMETHICONE, C12-15 ALKYL BENZOATE, PHENYL TRIMETHICONE, TALC, PEG-10 DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, GLYCERIN, ISOSTEARYL NEOPENTANOATE, GLYCERYL GLUCOSIDE, BIS-PEG/PPG-14/14 DIMETHICONE, ISODODECANE, PHENOXYETHANOL, SODIUM CHLORIDE, MICA, MAGNESIUM SULFATE, MENTHOXYPROPANEDIOL, SODIUM DEHYDROACETATE, HYDROGEN DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, BENZOIC ACID, C24-28 ALKYL METHICONE, DISTEARDIMONIUM HECTORITE SILICA, ALUMINUM HYDROXIDE, DEHYDROACETIC ACID, VACCINIUM MYRTILLUS FRUIT EXTRACT, PROPYLENE CARBONATE, ETHYLHEXYLGLYCERIN, LAURETH-4, POTASSIUM SORBATE, SODIUM BENZOATE, LACTIC ACID, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE; +/- MAY CONTAIN: TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499)

Package Labeling:kit

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 uses directed with others sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Apply generously 15 minutes before sun exposure
  • Reapply at least every 2 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 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

SHAKE WELL BEFORE USE

Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Other Information (Other information)

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

Package Labeling:

Active Ingredients (Active ingredients)

Octisalate 3.5%

Octocrylene 5%

Titanium dioxide 0.5%

Zinc Oxide 1.88%

Inactive Ingredients (Inactive ingredients)

WATER/EAU (AQUA), DIMETHICONE, C12-15 ALKYL BENZOATE, PHENYL TRIMETHICONE, TALC, PEG-10 DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, GLYCERIN, ISOSTEARYL NEOPENTANOATE, GLYCERYL GLUCOSIDE, BIS-PEG/PPG-14/14 DIMETHICONE, ISODODECANE, PHENOXYETHANOL, SODIUM CHLORIDE, MICA, MAGNESIUM SULFATE, MENTHOXYPROPANEDIOL, SODIUM DEHYDROACETATE, HYDROGEN DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, BENZOIC ACID, C24-28 ALKYL METHICONE, DISTEARDIMONIUM HECTORITE SILICA, ALUMINUM HYDROXIDE, DEHYDROACETIC ACID, VACCINIUM MYRTILLUS FRUIT EXTRACT, PROPYLENE CARBONATE, ETHYLHEXYLGLYCERIN, LAURETH-4, POTASSIUM SORBATE, SODIUM BENZOATE, LACTIC ACID, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE; +/- MAY CONTAIN: TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499)

Package Labeling:kit (Package Labeling:Kit)

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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