IN AN INSTANT  DAILY TINTED MOISTURIZER SPF 15- octinoxate, octisalate and avobenzone cream 
Guthy-Renker LLC.

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.

----------

In An Instant Daily Tinted Moisturizer, SPF 15

Drug Facts

Uses

Helps prevent sunburn. Higher SPF gives more sunburn protection.

Directions

Apply evenly onto face in the morning, before sun exposure and as needed. Tint will appear as you apply the lotion, acting as an indicator of complete and even coverage. Children under 6 months of age: ask a doctor.

WARNINGS

For external use only. Avoid contact with eyes. If contact occurs, flush gently and thoroughly with water.

Discontinue use if rash or irritation occurs.

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

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

OCTINOXATE 7.5%, OCTISALATE 5%, AVOBENZONE 2%

INACTIVE INGREDIENTS

WATER (AQUA), DIMETHICONE, CAPRYLlC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, STEARETH-2, POLYSILICONE-11, CETYL RICINOLEATE, DI-C12-15 ALKYL FUMARATE, PENTYLENE GLYCOL, STEARETH-21, POLYETHYLENE, COFFEA ARABICA (COFFEE) SEED EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT, ISOPROPYL MYRISTATE, VITIS VINIFERA (GRAPE) SEED EXTRACT, HORDEUM VULGARE EXTRACT, TRITICUM VULGARE (WHEAT) GERM EXTRACT, LAMINARIA OCHROLEUCA EXTRACT, ORYZANOL,CAMELLIA SINENSIS LEAF EXTRACT, ASPALATHUS LlNEARIS LEAF EXTRACT, POLYGONUM CUSPIDATUM ROOT EXTRACT, BETULA ALBA BARK EXTRACT, SACCHAROMYCES LYSATE EXTRACT, ASCORBYL TOCOPHERYL MALEATE, STEARYL ALCOHOL, TROMETHAMINE, GLYCERIN, CARBOMER, PHOSPHOLIPIDS, BENZYL ALCOHOL, POLYMETHYL METHACRYLATE, DISODIUM EDTA, LlNOLEIC ACID, CHOLESTEROL, BEHENYL ALCOHOL, SQUALANE, SODIUM PCA, SODIUM DEHYDROACETATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PANTETHINE, SODIUM HYDROXIDE, UREA, VP/HEXADECENE COPOLYMER, TREHALOSE, SODIUM HYALURONATE, POLYQUATERNIUM-51, PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER, CYCLODEXTRIN, MALTODEXTRIN, NORDIHYDROGUAIARETIC ACID, LINOLENIC ACID, LECITHIN, ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE, BHT, ETHYLPARABEN, ISOPROPYLPARABEN, BUTYLPARABEN, ISOBUTYLPARABEN, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE (PARFUM), TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)

PRINCIPAL DISPLAY PANEL - 15mL Tube Label

in an instant
HEIDI KLUM

Instant Daily
Tinted Moisturizer
SPF 15

hydrates and protects
with a sheer tint

0.5 fl. oz. / 15mL e

PRINCIPAL DISPLAY PANEL - 15mL Tube Label
IN AN INSTANT   DAILY TINTED MOISTURIZER SPF 15
octinoxate, octisalate, and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11410-749
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.075 mL  in 1 mL
Octisalate (Octisalate) Octisalate0.05 mL  in 1 mL
Avobenzone (Avobenzone) Avobenzone0.02 mg  in 1 mL
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-749-1750 mL in 1 TUBE
2NDC:11410-749-0315 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/25/2007
Labeler - Guthy-Renker LLC. (608315453)

Revised: 9/2010
Document Id: 0e620513-c4d8-4d0f-9eb6-350f8ebafe37
Set id: 9996b995-354d-444c-8db7-7d6552d85e21
Version: 1
Effective Time: 20100913
 
Guthy-Renker LLC.