ELF SPF 20 SUNSCREEN UVAUVB TINTED MOISTURIZER NUDE- octisalate cream

ELF SPF 20 Sunscreen UVAUVB Tinted Moisturizer Nude by

Drug Labeling and Warnings

ELF SPF 20 Sunscreen UVAUVB Tinted Moisturizer Nude by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Hangzhou Facecare Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Octinoxate: 7.5%

Octisalate: 5%

Oxybenzone: 3%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Helps prevent sunburn

WARNINGS

Warning:

For external use only

Skin Cancer/ Skin Aging Alert: Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown to only protect you from sunburn, not skin cancer or sking aging.

Do not use on damage 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 r ash 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.

Apply to clean skin in an upward and outward motion with sponage or foundation brush

Children under six months of age: ask a doctor.

Reapply at least 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, especially 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 this product in the container from excessive heat and direct sun

Store at room temperature 15-30 C (59-86F)

INACTIVE INGREDIENT

Inactive Ingredient:

Water, Dimethicone, Propylene Glycol,  C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Steareth-21, Steareth-2, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Xantahn Gum, Retinyl Palmitate (VA), Ascorbyl Palmitate (VC), Tocopheryl Acetate (VE), Butylene Glycol, Aloe Barbadensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract

May contain:

Titanium Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELF SPF 20 SUNSCREEN UVAUVB TINTED MOISTURIZER NUDE 
octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-633
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARETH-21 (UNII: 53J3F32P58)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
XANTHAN GUM (UNII: TTV12P4NEE)
VITAMIN A (UNII: 81G40H8B0T)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)
STEARETH-2 (UNII: V56DFE46J5)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-633-01	25 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/19/2019

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

Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Facecare Cosmetics Co., Ltd.		545341856	manufacture(76354-633)