ELF SPF 20 SUNSCREEN UVA/UVB TINTED MOISTURIZER IVORY- octinoxate cream

ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Ivory by

Drug Labeling and Warnings

ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Ivory by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai Tianle Daily Chemical Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Octisalate 5%

Oxybenzone 3%

Purpose

Sunscreen

Sunscreen

Sunscreen

Uses

• Helps prevent sunburn

Warnings

For external use only o Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or skin aging.

Do not use on damaged or broken skin.

When using

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures: Spending time in the sun increases your risk of sun 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 a.m-2 p.m
  • wear long-sleeved shirt, pants, hats and sunglasses
  • children under 6 months of age: Ask doctor.

Inactive ingredients

Water (Aqua), Propylene Glycol, C12-15 Allyl Benzoate, Dimethicone, Caprylic/Capric Triglyceride, Steareth 21, Steareth-2, Cetearyl Alcohol, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, Caprylyl Glycol, Ethylhexylglycerin, C13-14 Isoparaffin, Xanthan Gum, Laureth-7, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Butylene Glycol, Cucumis Sativus (Cucumber) Fruit Extract MAY CONTAIN: Titanium Dioxide (Cl 77891), Iron Oxide Yellow (Cl 77492), Red Iron Oxide (Cl 77491), Black Iron Oxide (Cl 77499)

Questions or comments? 1 -855-353-7320

Principal Display Panel - 25 mL Carton Label

e.l.f.

SPF 20 Suncreen UVA/UVB

Tinted Moisturizer

Ivory

Net Wt. 0.85 fl. oz. (25mL)

INGREDIENTS AND APPEARANCE

ELF SPF 20 SUNSCREEN UVA/UVB TINTED MOISTURIZER IVORY  
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-723
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DIMETHICONE (UNII: 92RU3N3Y1O)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-723-01	25 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/29/2015

Labeler - J. A. Cosmetics U.S. INC (186705047)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	MANUFACTURE(76354-723)