Huggies®

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (10 mg) Octinoxate (75 mg) Octisalate (50 mg) Octocrylene (8 mg) Oxybenzone

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2010-03-15

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Helps prevent sunburn.
Higher SPF gives more sunburn protection.
Retains SPF after 80 minutes of activity in the water or sweating.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

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

Warnings

For external use only.

Directions

Apply generously 15 minutes before sun exposure and as needed.
Reapply as needed or after towel drying, swimming or sweating.
Ask a doctor before use on children under six months of age.

Questions?

1-877-546-2273 Mo–Fr, 8 am–4 pm CT. Serious side effects associated with the use of this product may be reported to this number.

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Active Ingredients

Avobenzone 1%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 0.8%, Oxybenzone 5%

Inactive Ingredients

Water/Aqua, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Glycerin, Cetyl Phosphate, Caprylyl Glycol, Acrylates/C12 -22 Alkyl Methacrylate Copolymer, Dimethicone, Microcrystalline Cellulose, Phenoxyethanol, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Potassium Hydroxide, 1, 2- Hexanediol, Magnesium Aluminum Silicate, Cellulose Gum, Dimethiconol, Boron Nitride, Disodium EDTA, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Tropolone, Retinyl Palmitate, Tocopheryl Acetate, Fragrance/Parfum.

Principal Display Panel 44.4 Ml Label

Waterproof

HUGGIES ^®

Little

Swimmers ^®

Sunscreen Lotion

SPF

50

MANGO & COCONUT

Aloe & Vitamins A&E

Long-Lasting

UVA/UVB Protection

1.5 FL OZ (44.4 mL)

20-78-256-1-00

Structured Label Content

Uses

Helps prevent sunburn.
Higher SPF gives more sunburn protection.
Retains SPF after 80 minutes of activity in the water or sweating.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Purpose

Sunscreen

Warnings

For external use only.

Directions

Apply generously 15 minutes before sun exposure and as needed.
Reapply as needed or after towel drying, swimming or sweating.
Ask a doctor before use on children under six months of age.

Questions?

1-877-546-2273 Mo–Fr, 8 am–4 pm CT. Serious side effects associated with the use of this product may be reported to this number.

Other Information (Other information)

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Active Ingredients (Active ingredients)

Avobenzone 1%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 0.8%, Oxybenzone 5%

Inactive Ingredients (Inactive ingredients)

Water/Aqua, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Glycerin, Cetyl Phosphate, Caprylyl Glycol, Acrylates/C12 -22 Alkyl Methacrylate Copolymer, Dimethicone, Microcrystalline Cellulose, Phenoxyethanol, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Potassium Hydroxide, 1, 2- Hexanediol, Magnesium Aluminum Silicate, Cellulose Gum, Dimethiconol, Boron Nitride, Disodium EDTA, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Tropolone, Retinyl Palmitate, Tocopheryl Acetate, Fragrance/Parfum.

Principal Display Panel 44.4 Ml Label (PRINCIPAL DISPLAY PANEL 44.4 mL Label)

Waterproof

HUGGIES ^®

Little

Swimmers ^®

Sunscreen Lotion

SPF

50

MANGO & COCONUT

Aloe & Vitamins A&E

Long-Lasting

UVA/UVB Protection

1.5 FL OZ (44.4 mL)

20-78-256-1-00

Advanced Ingredient Data

[{"name": "Avobenzone", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Octinoxate", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Octisalate", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Octocrylene", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Oxybenzone", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of activity in the water or sweating.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash or irritation develops and lasts.", "50567-7": "When using this product, keep out of eyes. Rinse with water to remove.", "Purpose": "Sunscreen", "Warnings": "For external use only.", "Directions": "Apply generously 15 minutes before sun exposure and as needed. Reapply as needed or after towel drying, swimming or sweating. Ask a doctor before use on children under six months of age.", "Questions?": "1-877-546-2273 Mo–Fr, 8 am–4 pm CT. Serious side effects associated with the use of this product may be reported to this number.", "Other information": "Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.", "Active ingredients": "Avobenzone 1%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 0.8%, Oxybenzone 5%", "Inactive ingredients": "Water/Aqua, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Glycerin, Cetyl Phosphate, Caprylyl Glycol, Acrylates/C12 -22 Alkyl Methacrylate Copolymer, Dimethicone, Microcrystalline Cellulose, Phenoxyethanol, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Potassium Hydroxide, 1, 2- Hexanediol, Magnesium Aluminum Silicate, Cellulose Gum, Dimethiconol, Boron Nitride, Disodium EDTA, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Tropolone, Retinyl Palmitate, Tocopheryl Acetate, Fragrance/Parfum.", "PRINCIPAL DISPLAY PANEL 44.4 mL Label": "Waterproof HUGGIES ® Little Swimmers ® Sunscreen Lotion SPF 50 MANGO & COCONUT Aloe & Vitamins A&E Long-Lasting UVA/UVB Protection 1.5 FL OZ (44.4 mL) 20-78-256-1-00"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information