Sunscreen Mango And Coconut (Avobenzone, Octinoxate, Octisalate, Octocrylene, And Oxybenzone) Lotion [Kimberly-Clark Corporation] -

SUNSCREEN MANGO AND COCONUT (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [KIMBERLY-CLARK CORPORATION]
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NDC	55118-600-11
Set ID	aff60363-62f7-476c-accb-032e28e82793
Category	HUMAN OTC DRUG LABEL
Packager	Kimberly-Clark Corporation
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

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

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

For external use only.

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

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

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

Distributed by Kimberly-Clark
Global Sales, LLC, Neenah, WI
54956. Made in the U.S.
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

INGREDIENTS AND APPEARANCE

SUNSCREEN MANGO AND COCONUT
avobenzone, octinoxate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55118-600
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	10 mg in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	8 mg in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55118-600-11	45 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/15/2010

Labeler - Kimberly-Clark Corporation (006072136)

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Medic

SUNSCREEN MANGO AND COCONUT (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [KIMBERLY-CLARK CORPORATION]

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