Flawless Future Moisture Cream Broad Spectrum Sunscreen Spf 30

Flawless Future Moisture Cream Broad Spectrum Sunscreen Spf 30
SPL v3
SPL
SPL Set ID b553aec1-5002-3a3f-e053-2995a90a22e5
Route
TOPICAL
Published
Effective Date 2017-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.14 mg) Oxybenzone (4 mg) Octisalate (4.75 mg) Avobenzone (3 mg)
Inactive Ingredients
Jojoba Oil, Randomized Kefiran Caprylyl Glycol Caramel Cholesterol Glycyrrhizinate Dipotassium Isomethyl-.alpha.-ionone Stearyl Alcohol Water Glycerin Argan Oil Peg-100 Stearate Anhydrous Dextrose Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Shea Butter Cyclomethicone 5 Cetyl Alcohol Ceramide 1 Ceramide 6 Ii Edetate Disodium Anhydrous Ethylhexylglycerin Benzyl Salicylate Butylene Glycol Dimethicone Alkyl (c12-15) Benzoate Alpha-tocopherol Acetate Glyceryl Monostearate Phytosphingosine Propylene Glycol Hyaluronate Sodium Tocopherol .beta.-citronellol, (r)- Sodium Lauroyl Lactylate Xanthan Gum Butylated Hydroxytoluene Butylphenyl Methylpropional Chlorphenesin Hydroxyisohexyl 3-cyclohexene Carboxaldehyde Limonene, (+)- Phenoxyethanol Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Fucose Linalool, (+/-)- Sodium Benzoate Adenosine Ammonium Acryloyldimethyltaurate/vp Copolymer Levomenol Carbomer Homopolymer, Unspecified Type Ceramide 3 Geraniol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-06

Description

OCTINOXATE 7.14% OCTISALATE 4.75% OXYBENZONE 4.00% AVOBENZONE 3.00%


Medication Information

Warnings and Precautions
  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop using and ask a doctor if rash occurs.
Indications and Usage
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun
Dosage and Administration
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
Description

OCTINOXATE 7.14% OCTISALATE 4.75% OXYBENZONE 4.00% AVOBENZONE 3.00%

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 50565-1

Keep Out of Reach of Children. If product is swallowed, get medical help or contact a poison control center right away.

Section 55105-1

Sunscreen

Warnings
  • For external use only
  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Carton Art

Other Ingredients

WATER/AQUA/EAU, GLYCERIN, DIMETHICONE, ARGANIA SPINOSA KERNEL OIL, C12-15 ALKYL BENZOATE, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETYL ALCOHOL, STEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, ADENOSINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BISABOLOL, CAPRYLYL GLYCOL, CARAMEL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL, DIPOTASSIUM GLYCYRRHIZATE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, FUCOSE, GLUCOSE, GLUCURONIC ACID, HYDROLYZED SOY PROTEIN, HYDROLYZED YEAST PROTEIN, JOJOBA ESTERS, KEFIRAN, PANTHENOL, PARFUM/FRAGRANCE, PHYTOSPHINGOSINE, PROPYLENE GLYCOL, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, TOCOPHEROL, XANTHAN GUM, BHT, ALPHA-ISOMETHYL IONONE, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, GERANIOL, HEXYL CINNAMAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, SODIUM BENZOATE, RED 40 (CI 16035)

Active Ingredients

OCTINOXATE 7.14%

OCTISALATE 4.75%

OXYBENZONE 4.00%

AVOBENZONE 3.00%

Directions for Sunscreen Use
  • Apply liberally 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 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

  • Children under 6 months: Ask a doctor.

Structured Label Content

Uses (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.
Indications and Usage (34067-9)
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun
Dosage and Administration (34068-7)
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
Warnings and Precautions (34071-1)
  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop using and ask a doctor if rash occurs.
Section 50565-1 (50565-1)

Keep Out of Reach of Children. If product is swallowed, get medical help or contact a poison control center right away.

Section 55105-1 (55105-1)

Sunscreen

Warnings (WARNINGS)
  • For external use only
  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Carton Art (CARTON ART)

Other Ingredients (OTHER INGREDIENTS)

WATER/AQUA/EAU, GLYCERIN, DIMETHICONE, ARGANIA SPINOSA KERNEL OIL, C12-15 ALKYL BENZOATE, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETYL ALCOHOL, STEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, ADENOSINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BISABOLOL, CAPRYLYL GLYCOL, CARAMEL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL, DIPOTASSIUM GLYCYRRHIZATE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, FUCOSE, GLUCOSE, GLUCURONIC ACID, HYDROLYZED SOY PROTEIN, HYDROLYZED YEAST PROTEIN, JOJOBA ESTERS, KEFIRAN, PANTHENOL, PARFUM/FRAGRANCE, PHYTOSPHINGOSINE, PROPYLENE GLYCOL, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, TOCOPHEROL, XANTHAN GUM, BHT, ALPHA-ISOMETHYL IONONE, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, GERANIOL, HEXYL CINNAMAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, SODIUM BENZOATE, RED 40 (CI 16035)

Active Ingredients (ACTIVE INGREDIENTS)

OCTINOXATE 7.14%

OCTISALATE 4.75%

OXYBENZONE 4.00%

AVOBENZONE 3.00%

Directions for Sunscreen Use (DIRECTIONS FOR SUNSCREEN USE)
  • Apply liberally 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 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

  • Children under 6 months: Ask a doctor.

Advanced Ingredient Data


Raw Label Data

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