Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5e1b1cb3-3f23-4b72-925d-1d0214a9c29e
Route
TOPICAL
Published
Effective Date 2011-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 mL) Homosalate (8 mL) Octisalate (4 mL) Oxybenzone (5 mL)
Inactive Ingredients
Acetyl Hexapeptide-3 Alcohol Water Benzoic Acid Butylene Glycol Butylparaben Alkyl (c12-15) Benzoate Cetostearyl Alcohol C12-20 Alkyl Glucoside Cyclomethicone 5 Dehydroacetic Acid Dimethicone Ethylhexylglycerin Ethylparaben Glycerin Glyceryl Monostearate Himanthalia Elongata Isobutylparaben Linalool, (+)- Magnesium Ascorbyl Phosphate Methylisothiazolinone Methylparaben Panthenol Phenoxyethanol Lecithin, Soybean Porphyra Umbilicalis Potassium Sorbate Propylparaben Vitamin A Palmitate Silicon Dioxide Solidago Virgaurea Flowering Top Spirulina Maxima .alpha.-tocopherol Acetate, Dl- Triethanolamine Hydrochloride Trisiloxane Tropaeolum Majus Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-01

Description

Avobenzone 3.0% Homosalate 8.0% Octisalate 4.0% Oxybenzone 5.0%


Medication Information

Warnings and Precautions

• For external use only • Do not use on damaged or broken skin

• Stop use and ask a doctor if rash occurs

• Keep out of eyes, Rinse with water to remove. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away
Dosage and Administration

• For Sunscreen use

• Apply liberally 15 minutes before sun exposure

• Use water resistance sunscreen if swimming or sweating

• Reapply at least every 2 hours

• Children under 6 months: Ask a doctor

Description

Avobenzone 3.0% Homosalate 8.0% Octisalate 4.0% Oxybenzone 5.0%

Section 44425-7

Protect the product in this container from excessive heat

and direct sun

Section 51727-6

Acetyl Hexapeptide-8, Alcohol, Aqua/Water/Eau,

Benzoic Acid, Butylene Glycol, Butylparaben,

C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl

Glucoside, Cyclopentasiloxane, Dehydroacetic

Acid, Dimethicone, Ethylhexylglycerin,

Ethylparaben, Glycerin, Glyceryl Stearate,

Himanthalia Elongata Extract, Isobutylparaben,

Linalool, Magnesium Ascorbyl Phosphate,

Methylisothiazolinone, Methylparaben,

Panthenol, Parfum/Fragrance, Phenoxyethanol,

Phospholipids, Polyaminopropyl Biguanide,

Porphyra Umbilicalis Extract, Potassium Sorbate,

Propylparaben, Retinyl Palmitate, Silica,

Solidago Virgaurea (Goldenrod) Extract,

Spirulina Maxima Extract, Tocopheryl Acetate,

Triethanolamine, Trisiloxane, Tropaeolum Majus

Flower Extract, Xanthan Gum

Section 51945-4

Image of Label Carton srlr276.jpg

Section 55105-1

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9


Avobenzone 3.0%

Homosalate 8.0%

Octisalate 4.0%

Oxybenzone 5.0%


Structured Label Content

Dosage and Administration (34068-7)

• For Sunscreen use

• Apply liberally 15 minutes before sun exposure

• Use water resistance sunscreen if swimming or sweating

• Reapply at least every 2 hours

• Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

• For external use only • Do not use on damaged or broken skin

• Stop use and ask a doctor if rash occurs

• Keep out of eyes, Rinse with water to remove. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away
Section 44425-7 (44425-7)

Protect the product in this container from excessive heat

and direct sun

Section 51727-6 (51727-6)

Acetyl Hexapeptide-8, Alcohol, Aqua/Water/Eau,

Benzoic Acid, Butylene Glycol, Butylparaben,

C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl

Glucoside, Cyclopentasiloxane, Dehydroacetic

Acid, Dimethicone, Ethylhexylglycerin,

Ethylparaben, Glycerin, Glyceryl Stearate,

Himanthalia Elongata Extract, Isobutylparaben,

Linalool, Magnesium Ascorbyl Phosphate,

Methylisothiazolinone, Methylparaben,

Panthenol, Parfum/Fragrance, Phenoxyethanol,

Phospholipids, Polyaminopropyl Biguanide,

Porphyra Umbilicalis Extract, Potassium Sorbate,

Propylparaben, Retinyl Palmitate, Silica,

Solidago Virgaurea (Goldenrod) Extract,

Spirulina Maxima Extract, Tocopheryl Acetate,

Triethanolamine, Trisiloxane, Tropaeolum Majus

Flower Extract, Xanthan Gum

Section 51945-4 (51945-4)

Image of Label Carton srlr276.jpg

Section 55105-1 (55105-1)

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9 (55106-9)


Avobenzone 3.0%

Homosalate 8.0%

Octisalate 4.0%

Oxybenzone 5.0%


Advanced Ingredient Data


Raw Label Data

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