DDF ULTRA-LITE OIL-FREE MOISTURIZING DEW UV MOISTURIZER SPF 15 - avobenzone, homosalate, octisalate and octocrylene lotion
Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Homosalate 5.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Octocrylene 2.6%	Sunscreen

Use

helps prevent sunburn.

Warnings

For external use only.

Do not use on irritated or broken skin.

Stop use and ask a physician if rash, irritation or sensitivity develops and lasts.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

apply evenly before sun exposure and as needed.
children under 6 months of age: consult a doctor

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, glycerin, polyethylene, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, pentylene glycol, sodium PCA, benzyl alcohol, tocopheryl acetate, stearyl alcohol, behenyl alcohol, cetyl alcohol, panthenol, isohexadecane, dimethiconol, allantoin, cetearyl glucoside, cetearyl alcohol, PEG-100 stearate, disodium EDTA, propylparaben, iodopropynyl butylcarbamate, PEG-4, PEG-4 laurate, PEG-4 dilaurate, triethanolamine, phenoxyethanol, polysorbate 60, stearic acid, BHT, vitis vinifera (grape) seed extract, retinyl palmitate, aloe barbadensis leaf juice, sodium hyaluronate, ascorbic acid, methylparaben, ethylparaben.

Dist. by HDS Cosmetics Lab, Inc.
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 48 g Bottle Carton

DDF®
DOCTOR'S DERMATOLOGIC FORMULA

ULTRA-LITE
OIL-FREE
MOISTURIZING
DEW™
UV MOISTURIZER
SPF 15 LOTION

PROTECT

UVA•UVB protection
Absorbs quickly
Fragrance-free
Replenishes moisture

SENSITIVE

NETWT.1.7 OZ. e 48 g

DDF ULTRA-LITE OIL-FREE MOISTURIZING DEW UV MOISTURIZER SPF 15
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-713
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (Avobenzone)	Avobenzone	0.03 g in 1 g
Homosalate (Homosalate)	Homosalate	0.05 g in 1 g
Octisalate (Octisalate)	Octisalate	0.05 g in 1 g
Octocrylene (Octocrylene)	Octocrylene	0.026 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
water
glycerin
dimethicone
pentylene glycol
SODIUM PYRROLIDONE CARBOXYLATE
benzyl alcohol
stearyl alcohol
DOCOSANOL
cetyl alcohol
panthenol
isohexadecane
allantoin
cetearyl glucoside
CETOSTEARYL ALCOHOL
PEG-100 stearate
EDETATE DISODIUM
propylparaben
iodopropynyl butylcarbamate
POLYETHYLENE GLYCOL 200
PEG-4 laurate
PEG-4 dilaurate
TROLAMINE
phenoxyethanol
polysorbate 60
stearic acid
BUTYLATED HYDROXYTOLUENE
VITIS VINIFERA SEED
VITAMIN A PALMITATE
ALOE VERA LEAF
HYALURONATE SODIUM
ascorbic acid
methylparaben
ethylparaben

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37000-713-48	1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON	contains a BOTTLE, PUMP
1		48 g in 1 BOTTLE, PUMP	This package is contained within the CARTON (37000-713-48)
2	NDC:37000-713-28	28 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2011

Labeler - Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Operations
UPSI (Diversapack of California)		177711082	MANUFACTURE

Revised: 08/2011 Procter & Gamble Manufacturing Company