Sun Diffusing Protector Spf 15

Sun Diffusing Protector Spf 15
SPL v6
SPL
SPL Set ID 6550938a-7299-4e4b-aafe-4d5ce13e79a5
Route
TOPICAL
Published
Effective Date 2012-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 mL) Octisalate (5 mL) Oxybenzone (3 mL) Titanium Dioxide (0.01 mL) Zinc Oxide
Inactive Ingredients
Sorbitol Alkyl (c12-15) Benzoate Stearic Acid Cetyl Alcohol Dimethicone Lavender Oil Sage Oil Citrus Aurantium Fruit Oil Citrus Aurantium Flower Oil Imidurea Methylparaben Propylparaben Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-01-01

Description

Active Ingredients                           Purpose Octinoxate 7.5 %                           Sunscreen Octisalate 5%                                Sunscreen Oxybenzone 3%                            Sunscreen Titanium Dioxide 0.01%                  Sunscreen zinc Oxide 0.01%                           Sunscreen


Medication Information

Warnings and Precautions

Warnings

For external use only.

When using this product: keep out of eyes. Rinse with water to remove.

Indications and Usage


Stop use and ask a doctor if rash and irritation develops and lasts

Dosage and Administration


Directions

Apply liberally 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming  or perspiring. Children under 6 months, ask a doctor.

Description

Active Ingredients                           Purpose Octinoxate 7.5 %                           Sunscreen Octisalate 5%                                Sunscreen Oxybenzone 3%                            Sunscreen Titanium Dioxide 0.01%                  Sunscreen zinc Oxide 0.01%                           Sunscreen

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

Section 51727-6


Inactive Ingredients

Water (aqua) (eau), sorbitol, c12-15 alkyl benzoate, DEA cetyl phosphate, stearic acid, cetyl alcohol, dimethicone, carbomer, Lavendula Augustifolia (Lavender) oil, Salvia Officinalis (sage) Oil, Salvia sclarea (clary sage) oil, Citrus aurantium (petitgrain cordillera) oil, Citrus Aurantium (neroli) oil, Lavendula Hybridia (Lavendin) Oil, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine.











Section 51945-4

Sun Diffusing Protector SPF 15

Broad Spectrum UVA/UVB protection

Moisturizing Formula

177 mL / 6 Fl. Oz.







Section 55105-1

Uses

For skin highly sensitive to sunburn

Section 55106-9

Active Ingredients                           Purpose

Octinoxate 7.5 %                           Sunscreen

Octisalate 5%                                Sunscreen

Oxybenzone 3%                            Sunscreen

Titanium Dioxide 0.01%                  Sunscreen

zinc Oxide 0.01%                           Sunscreen


Structured Label Content

Indications and Usage (34067-9)


Stop use and ask a doctor if rash and irritation develops and lasts

Dosage and Administration (34068-7)


Directions

Apply liberally 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming  or perspiring. Children under 6 months, ask a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only.

When using this product: keep out of eyes. Rinse with water to remove.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

Section 51727-6 (51727-6)


Inactive Ingredients

Water (aqua) (eau), sorbitol, c12-15 alkyl benzoate, DEA cetyl phosphate, stearic acid, cetyl alcohol, dimethicone, carbomer, Lavendula Augustifolia (Lavender) oil, Salvia Officinalis (sage) Oil, Salvia sclarea (clary sage) oil, Citrus aurantium (petitgrain cordillera) oil, Citrus Aurantium (neroli) oil, Lavendula Hybridia (Lavendin) Oil, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine.











Section 51945-4 (51945-4)

Sun Diffusing Protector SPF 15

Broad Spectrum UVA/UVB protection

Moisturizing Formula

177 mL / 6 Fl. Oz.







Section 55105-1 (55105-1)

Uses

For skin highly sensitive to sunburn

Section 55106-9 (55106-9)

Active Ingredients                           Purpose

Octinoxate 7.5 %                           Sunscreen

Octisalate 5%                                Sunscreen

Oxybenzone 3%                            Sunscreen

Titanium Dioxide 0.01%                  Sunscreen

zinc Oxide 0.01%                           Sunscreen


Advanced Ingredient Data


Raw Label Data

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