ELF Beauty Shield SPF 50 Skin Shielding Moisturizer by J. A. Cosmetics U.S. INC / Hangzhou Facecare Cosmetics Co., Ltd. Drug Fact

ELF Beauty Shield SPF 50 Skin Shielding Moisturizer by

Drug Labeling and Warnings

ELF Beauty Shield SPF 50 Skin Shielding Moisturizer 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]

ELF BEAUTY SHIELD SPF 50 SKIN SHIELDING MOISTURIZER- titanium dioxide 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:

Titanium Dioxide: 11.0%

Octinoxate: 7.5%

Octocrylene: 5.0%

Octisalate: 5.0%

Oxybenzone: 4.0%

Purpose:

Sunscreen

Uses:

Helps prevent sunburn

If used as directed (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warning:

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.

Stop Use and Ask a Doctor if:

Rash occurs

Keep Out of Reach of Children

Directions:

For suncreen use:

Apply liberally 15 min before sun exposure.

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

Inactive Ingredient:

Water, Cyclopentasiloxane, Isododecane,C12-15 Alkyl Benzoate, Silica, Phenyl Trimethicone, Butyloctyl Salicylate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone,Phenethyl Benzoate, Dimethicone, VP/Hexadecene Copolymer, Sodium Chloride, Dimethicone/Vinyl Methicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Cetyl PEG/PEG-10/1 Dimethicone, Disteardimonium Hectorite, Propylene Carbonate, Bisabolol, Ascorbyl Palmitate (VC), Helianthus Annuus (Sunflower) Seed Oil, Daucus Carota Sativa (Carrot) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Beta Carotene, Disodium EDTA, Talc, Alumina, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Fragrance

May contain:

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

ELF BEAUTY SHIELD SPF 50 SKIN SHIELDING MOISTURIZER 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.0 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PHENETHYL BENZOATE (UNII: 0C143929GK)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARROT JUICE (UNII: QXF936IX43)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CARROT SEED OIL (UNII: 595AO13F11)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
DISODIUM HEDTA (UNII: KME849MC7A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CAROTENE (UNII: 01YAE03M7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-803-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2017	12/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/26/2017	12/05/2019

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

Revised: 5/2017

Document Id: 4fdb1113-d15a-40d7-b1fb-15eb779be9a2

34390-5

Set id: 56c45e85-d24e-4a65-ae63-85e54f940125

Version: 2

Effective Time: 20170527

 

J. A. Cosmetics U.S. INC