ELTA SKINCARE BROAD-SPECTRUM SUNSCREEN TINTED  SPF36- zinc oxide lotion 
CP Skin Health Group, 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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Elta MD Skincare Broad Spectrum SPF 36 Tinted

Active Ingredients

  Zinc Oxide 20.2%

Purpose

  Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see  ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun  

Warnings

  For external use only

Do not Use

  on damaged or broken skinn

When using this product

keeep out of eyes. Rinse with water to remove

Stop use and ask a physician

if rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a poison control center right away

Directions

  • apply liberally 15 minutes before sun exposre
  • use a water-resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • ​Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of SPF15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a physician

Other information

protect this product from excessive hear and direct sun

Inactive Ingredients

Water, Coco-Caprylate/Caprate, Niacinamide, Isopropyl Myristate, Polyglyceryl-3 Diisostearate, Ethyl Macadamiate, Mica, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Nonanoate, Propanediol, Undecane, Caprylic/Capric Triglyceride, Tridecane, Polyglyceryl-3 Polyricinoleate, Disteardimonium Hectorite, Phenoxyethanol, Octyldodecyl Oleate, Magnesium Sulfate, Sodium Chloride, Tocopheryl Acetate, Isostearic Acid, Cocos Nucifera (Coconut) Fruit Extract, Xanthan Gum, Bisabolol, Silica, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Lactic Acid, Tocopherol, Malic Acid, Zingiber Officinale (Ginger) Root Extract, Ergothioneine.

May contain Titanium Dioxide (CI 77891), Iron Oxide(CI 77491), Iron Oxides(CI 77492), Iron Oxides (CI 77499)

UVGLOWUCtint

ELTA SKINCARE BROAD-SPECTRUM SUNSCREEN TINTED   SPF36
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-0422
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
MICA (UNII: V8A1AW0880)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
CETEARYL NONANOATE (UNII: F6ZWV2F361)  
PROPANEDIOL (UNII: 5965N8W85T)  
UNDECANE (UNII: JV0QT00NUE)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TRIDECANE (UNII: A3LZF0L939)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LEVOMENOL (UNII: 24WE03BX2T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALOE (UNII: V5VD430YW9)  
LACTIC ACID (UNII: 33X04XA5AT)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MALIC ACID (UNII: 817L1N4CKP)  
GINGER (UNII: C5529G5JPQ)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-0422-21 in 1 CARTON12/10/2020
1NDC:72043-0422-148 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/10/2020
Labeler - CP Skin Health Group, Inc (611921669)

Revised: 11/2022
 
CP Skin Health Group, Inc