Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3 mL) Homosalate (8 mL) Octisalate (4 mL) Oxybenzone (5 mL)

Inactive Ingredients

Water Isomethyl-.alpha.-ionone Ascophyllum Nodosum Benzyl Benzoate Benzyl Salicylate Butylene Glycol Butylphenyl Methylpropional Alkyl (c12-15) Benzoate Cetostearyl Alcohol Cetearyl Glucoside Citronellol Acetate, (s)- Cyclomethicone 5 Dimethicone Edetic Acid Ethylhexylglycerin Glycerin Glyceryl Monostearate Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Hydroxyisohexyl 3-cyclohexene Carboxaldehyde Isohexadecane Laminaria Digitata Limonene, (+)- Linalool, (+/-)- Magnesium Chloride Magnesium Nitrate Methylchloroisothiazolinone Methylisothiazolinone Morus Australis Root Peg-100 Stearate Phenoxyethanol Polysorbate 60 Propylene Glycol Saxifraga Stolonifera Leaf Scutellaria Baicalensis Root Sodium Metabisulfite Sodium Sulfite Spirulina Maxima .alpha.-tocopherol Acetate, Dl- Triethanolamine Hydrochloride Trisiloxane Vitis Vinifera Flowering Top Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-03-01

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 50567-7

• Helps prevent sunburn

• If used as directed with other sun protection measures

(see directions) decreases the risk of skin cancers and early skin aging

Section 51727-6

Aqua/Water/Eau, Alpha-Isomethyl Ionone, Ascophyllum Nodosum Extract, Ascorbyl

Glucoside, Benzyl Benzoate, Benzyl Salicylate, Butylene Glycol, Butylphenyl

Methylpropional, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside,

Citronellol, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexylglycerin,

Fragrance (Parfum), Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde,

Isohexadecane, Laminaria Digitata Extract, Limonene, Linalool, Magnesium Chloride,

Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Morus

Bombycis Root Extract, PEG-100 Stearate, Phenoxyethanol, Plankton Extract,

Polysorbate 60, Propylene Glycol, Saxifraga Sarmentosa Extract, Scutellaria

Baicalensis Root Extract, Sodium Metabisulfite, Sodium Sulfite, Sorbitan Isostearate,

Spirulina Maxima Extract, Tocopheryl Acetate, Triethanolamine, Trisiloxane, Vitis

Vinifera (Grape) Fruit Extract, Xanthan Gum

Section 51945-4

Image of carton label wwa250.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 50567-7 (50567-7)

• Helps prevent sunburn

• If used as directed with other sun protection measures

(see directions) decreases the risk of skin cancers and early skin aging

Section 51727-6 (51727-6)

Aqua/Water/Eau, Alpha-Isomethyl Ionone, Ascophyllum Nodosum Extract, Ascorbyl

Glucoside, Benzyl Benzoate, Benzyl Salicylate, Butylene Glycol, Butylphenyl

Methylpropional, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside,

Citronellol, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexylglycerin,

Fragrance (Parfum), Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde,

Isohexadecane, Laminaria Digitata Extract, Limonene, Linalool, Magnesium Chloride,

Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Morus

Bombycis Root Extract, PEG-100 Stearate, Phenoxyethanol, Plankton Extract,

Polysorbate 60, Propylene Glycol, Saxifraga Sarmentosa Extract, Scutellaria

Baicalensis Root Extract, Sodium Metabisulfite, Sodium Sulfite, Sorbitan Isostearate,

Spirulina Maxima Extract, Tocopheryl Acetate, Triethanolamine, Trisiloxane, Vitis

Vinifera (Grape) Fruit Extract, Xanthan Gum

Section 51945-4 (51945-4)

Image of carton label wwa250.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

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"strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 60", "unii": "CAL22UVI4M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SAXIFRAGA STOLONIFERA LEAF", "unii": "O3TMV4903H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", 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Raw Label Data

All Sections (JSON)

{"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", "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", "44425-7": "Protect the product in this container from excessive heat and direct sun", "50567-7": "• Helps prevent sunburn • If used as directed with other sun protection measures (see directions) decreases the risk of skin cancers and early skin aging", "51727-6": "Aqua/Water/Eau, Alpha-Isomethyl Ionone, Ascophyllum Nodosum Extract, Ascorbyl Glucoside, Benzyl Benzoate, Benzyl Salicylate, Butylene Glycol, Butylphenyl Methylpropional, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Citronellol, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance (Parfum), Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Isohexadecane, Laminaria Digitata Extract, Limonene, Linalool, Magnesium Chloride, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Morus Bombycis Root Extract, PEG-100 Stearate, Phenoxyethanol, Plankton Extract, Polysorbate 60, Propylene Glycol, Saxifraga Sarmentosa Extract, Scutellaria Baicalensis Root Extract, Sodium Metabisulfite, Sodium Sulfite, Sorbitan Isostearate, Spirulina Maxima Extract, Tocopheryl Acetate, Triethanolamine, Trisiloxane, Vitis Vinifera (Grape) Fruit Extract, Xanthan Gum", "51945-4": "Image of carton label wwa250.jpg", "55105-1": "Sunscreen Sunscreen Sunscreen Sunscreen", "55106-9": "Avobenzone 3.0% Homosalate 8.0% Octisalate 4.0% Oxybenzone 5.0%"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information