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

ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Nude by

Drug Labeling and Warnings

ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Nude 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 INGREDIENT

Active Ingredient:

OCTINOXATE: 7.5%

OCTISALATE: 5.0%

OXYBENONE: 3.0%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Help prevent sunburn

WARNINGS

Warning:

For external use only

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 sunbrun, not skin cancer or skin aging.

Do not use on damaged or broken skin

WHEN USING

When using this product:

Keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop Use and Ask a Doctor if:

Rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

DOSAGE & ADMINISTRATION

Directions:

For sunscreen use:

Apply generously 15 min before sun exposure. Reapply every two hours.

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures:

Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including

• Limit time in the sun, es[ecially from 10 am to 2 pm
• Wear long sleeved shirts, pants, hats, and sunglasses.
• Children under six months of age: ask a doctor

OTHER SAFETY INFORMATION

Other Information

Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive Ingredient:

Water,Paraffinum Liquidum (Minearal Oil), Propylene Glycol, C12-15 Akyl Benzoate,Caprylic/Capric Triglyceride, Steareth-21, Dimethicone, Steareth-2, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Xanthan Gum, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, DMDN Hydantoin, Iodopropynyl Butylcarbamate, Retinyl Palmitate (VA), Topopheryl Acetate (VE), Magnesium Ascorbyl Phsophate (VC), Aloe Vera Leaf Juice, Cucumis Sativus (Cucumber) Fuit Extract

May contain:

Titanium Dioxide (CI77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-717
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: 76354-717-01	25 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2015	01/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/29/2015	01/12/2021

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