COPPERSTONE WATER BABIES PURE AND SIMPLE WHIPPED SUNSCREEN BROAD SPECTRUM SPF 50 SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Copperstone Water Babies Pure and Simple Whipped Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Copperstone Water Babies Pure and Simple Whipped Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,
Octocrylene 4%, Oxybenzone 6%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection increases (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on 

damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.
• use only as directed. Intentional misue by deliberately concentrating and inhaling the contents can be harmful or fatal.
• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• do not dispense or apply directly on face. Dispense into hands and apply to face
• use in well-ventillated areas
• reapply:
• after 80 minutes if swimming or sweating
• imediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscereen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Other Information

• protect this product from excessive heat and direct sun
• avoid long term storage above 40°C (104°F)
• may stain or damage some fabrics or surfaces

Inactive ingredients

Water, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Glycerin, Styrene/Acrylates Copolymer, Dicaprylyl Ether, Microcrystalline Cellulose, Glyceryl Stearate, Cetyl Alcohol, Benzyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, Myristyl Alcohol, Chlorphenesin, Tocopherol (Vitamin E), Cellulose Gum, Lecithin, Disodium EDTA, Lauryl Alcohol, Sodium Ascorbyl Phosphate, Fragrance, Nitrous Oxide.

Questions?

1-866-288-330

Package Labeling:

INGREDIENTS AND APPEARANCE

COPPERSTONE WATER BABIES PURE AND SIMPLE WHIPPED SUNSCREEN BROAD SPECTRUM SPF 50   SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23667-802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
WATER (UNII: 059QF0KO0R)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CHLORPHENESIN (UNII: I670DAL4SZ)
TOCOPHEROL (UNII: R0ZB2556P8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LAURYL ALCOHOL (UNII: 178A96NLP2)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
NITROUS OXIDE (UNII: K50XQU1029)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23667-802-01	142 g in 1 CAN; Type 0: Not a Combination Product	02/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/09/2017

Labeler - Formulated Solutions, LLC (143266687)