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NDC 00311-0706-01 Almay Age Smart Shade CC Luminous Primer SPF 15 4.3; 3.3 mg/mL; mg/mL Details

Almay Age Smart Shade CC Luminous Primer SPF 15 4.3; 3.3 mg/mL; mg/mL

Almay Age Smart Shade CC Luminous Primer SPF 15 is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Almay, Inc.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	00311-0706
Product ID	0311-0706_9585cbfc-e6d9-312f-e053-2995a90a51fb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Almay Age Smart Shade CC Luminous Primer SPF 15
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide, Titanium Dioxide Make-Up
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	4.3; 3.3
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Almay, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00311-0706-01 (00311070601)

Pricing Information	N/A
NDC Package Code	0311-0706-01
Billing NDC	00311070601
Package	30 mL in 1 BOTTLE, GLASS (0311-0706-01)
Marketing Start Date	2013-11-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 281557c0-e668-4436-86a7-3f583091e4e4 Details

Active Ingredients:

Zinc Oxide: 3.3%

Titanium Dioxide 4.3%

Purpose

Sunscreen

Uses:

•Helps prevent sunburn

•If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

•For external use only

•Do notuse on damaged or broken skin

•When using this product: Keep out of eyes. Rinse with water to remove.

•Stop use and ask a doctor if a 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

•Use a water resistant sunscreen if swimming or sweating

•Reapply at least every 2 hours

•Children under 6 months: Ask a doctor.

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 sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

•Limit time in the sun, especially from 10 am - 2 pm

•Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Aqua ((Water) Eau), Cyclopentasiloxane, Dimethicone, Phenyl Trimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, Boron Nitride, Adipic Acid/Neopentyl Glycol Crosspolymer, Trimethylsiloxysilicate, Butylene Glycol, Disteardimonium Hectorite, Dimethicone/PEG-10/15 Crosspolymer, Alumina, Dimethicone Crosspolymer, Methyl Acetylglycyrrhetinoyl Hydroxyprolinate, Thermus Thermophillus Ferment, Alpha-Glucan Oligosaccharide, Polymnia Sonchifolia Root Juice, Tocopherol, Niacinamide, Methylsilanol Hydroxyproline Aspartate, Lactobacillus, Hydrolyzed Triticum Monococcum Seed Extract, Maltodextrin, Sodium Chloride, Polyglyceryl-3 Diisostearate, Methicone, Xanthan Gum, Triethoxycaprylylsilane, Isopropyl Titanium Triisostearate, Polymethyl Methacrylate, Sodium Citrate, Dipropylene Glycol, Sodium Benzoate, Tetrasodium EDTA, Phenoxyethanol, Methylparaben, Ethylparaben, Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499)

Principal Display Panel

Almay

Smart Shade CC Luminous Primer

Broad Spectrum

SPF 15

1.0 fL. OZ/30 mL

INGREDIENTS AND APPEARANCE

ALMAY AGE SMART SHADE CC LUMINOUS PRIMER SPF 15

zinc oxide, titanium dioxide make-up liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0311-0706
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.3 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
NIACINAMIDE (UNII: 25X51I8RD4)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE SODIUM (UNII: MP1J8420LU)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0311-0706-01	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/14/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/14/2013

Labeler - Almay, Inc. (064988652)

Name	Address	ID/FEI	Business Operations
Establishment
REVLON, INC.		809725570	manufacture(0311-0706)

Revised: 10/2019

Document Id: 9585cbfc-e6d9-312f-e053-2995a90a51fb

Set id: 281557c0-e668-4436-86a7-3f583091e4e4

Version: 2

Effective Time: 20191022