DailyMed - SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA COSMETICS- octinoxate, octisalate, oxybenzone cream

Contains inactivated NDC Code(s)
NDC Code(s): 68828-117-01, 68828-117-02
Packager: Jafra Cosmetics International Inc

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 11, 2019

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ACTIVE INGREDIENT
Active Ingredients       Purpose - Octinoxate 7%             Sunscreen - Octisalate 3%                Sunscreen - Oxybenzone 2%            Sunscreen - Uses - helps prevent sunburn - if used as ...

Active Ingredients       Purpose

Octinoxate 7%             Sunscreen

Octisalate 3%                Sunscreen

Oxybenzone 2%            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

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

Stop use and ask a doctor if rash occurs

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.

Directions
Apply liberally 15 minutes before sun exposure
   Reapply at least every 2 hours
   Use a water resistant sunscreen if swimming or sweating
   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 broad spectrum SPF 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

Inactive ingredients
Water/Aqua, Butylene Glycol, Glyceryl Stearate, Stearic Acid, Isopropyl Isostearate, Di-PPG-3 Myristyl Ether Adipate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Triethanolamine, Lecithin, Silica, Dimethicone, Polysorbate 20, Hydrolyzed Lupinus Albus (Lupine) Protein, Medicago Sativa (Alfalfa) Seed Extract, DMDM Hydantoin, Xanthan Gum, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Magnesium Aluminum Silicate, Tocopheryl Acetate, Tagetus Erecta (African Marigold) Extract, Ipomoea Batatas Tuber Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA [May Contain +/- : Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI 77492/CI 77499]

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PRINCIPAL DISPLAY PANEL
Skin Defense Concealer Broad Spectrum SPF 15 - 15 ml .5 Fl Oz (US)

Skin Defense Concealer Broad Spectrum SPF 15

15 ml .5 Fl Oz (US)

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INGREDIENTS AND APPEARANCE

Product Information

SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA COSMETICS octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68828-117
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALFALFA (UNII: DJO934BRBD)
DMDM HYDANTOIN (UNII: BYR0546TOW)
XANTHAN GUM (UNII: TTV12P4NEE)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SWEET POTATO (UNII: M9WGG9Z9GK)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
EDETATE TRISODIUM (UNII: 420IP921MB)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68828-117-02	1 in 1 PACKAGE	05/22/2013
1	NDC:68828-117-01	30 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/22/2013

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-117)

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Published Date (What is this?)	Version	Files
Jun 12, 2019	2 (current)	download
May 23, 2013	1	download

Label: SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA COSMETICS- octinoxate, octisalate, oxybenzone cream

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	NDC
1	68828-117-01
2	68828-117-02 (inactivated)

Label: SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA COSMETICS- octinoxate, octisalate, oxybenzone cream

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SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA COSMETICS- octinoxate, octisalate, oxybenzone cream

Number of versions: 2

SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA COSMETICS- octinoxate, octisalate, oxybenzone cream

SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA COSMETICS- octinoxate, octisalate, oxybenzone cream

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SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA COSMETICS- octinoxate, octisalate, oxybenzone cream

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.