ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Sand by J. A. Cosmetics U.S. INC / Shanghai Tianle Daily Chemical Factory Drug Fact

ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Sand by

Drug Labeling and Warnings

ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Sand 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]

ELF SPF 20 SUNSCREEN UVA/UVB TINTED MOISTURIZER SAND- octinoxate cream 
J. A. Cosmetics U.S. INC

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.

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Drug Fact

Active Ingredient:

OCTINOXATE: 7.5%

OCTISALATE: 5.0%

OXYBENONE: 3.0%

Purpose:

Sunscreen

Uses:

Help prevent sunburn

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 this product:

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask a Doctor if:

Rash occurs

Keep Out of Reach of Children

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 Information

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

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)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-719
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: 76354-719-01	25 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2015	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/29/2015	12/31/2018

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

Revised: 8/2015

Document Id: 34c8ebcc-b181-4f0e-96e9-c119a1d6cd4c

34390-5

Set id: 034cfd47-c8df-417a-bf3e-88d65a2928a4

Version: 2

Effective Time: 20150830

 

J. A. Cosmetics U.S. INC