SPF 50 UVA/UVB- ensulizole, oxybenzone, avobenzone, octocrylene cream 
MULTALER ET CIE S.A.S.

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SPF 50 UVA UVB

Drug Facts

Octocrylene 8%

Oxybenzone / benzophenone-3 5%

Avobenzone / butyl methoxydibenzoylmethane 3%

Ensulizole / phenylbenzimidazole sulfonic acid 3%

Purpose

Sunscreen

Uses

  • helps prevent sunburn.

Warnings

For external use only.

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if rash occurs.

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact poison control center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor
  • 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m-2 p.m
  • wear long-sleeved shirts, pants, and sunglasses.

Ingredients

Aqua/water, c12-15 alkyl benzoate, octocrylene, glyceryl stearate, benzophenone-3 /oxybenzone, ppg-12/smdi copolymer, glycerin, butyl methoxydibenzoylmethane/avobenzone, phenylbenzimidazole sulfonic acid/ensulizole, peg-100 stearate, tromethamine, magnesium aluminum silicate, propylene glycol, prunus armeniaca (apricot) kernel oil, sorbitan stearate, caprylyl glycol, bisabolol, dimethicone, chlorphenesin, xanthan gum, sodium acrylate/ sodium acryloyldimethyl taurate copolymer, tocopheryl acetate, panthenol, caprylhydroxamic acid, camellia sinensis leaf extract, isohexadecane, tetrasodium edta, retinyl palmitate, dipotassium glycyrrhizate, maltodextrin, polysorbate 80, aspalathus linearis leaf extract, helianthus annuus (sunflower) seed oil, pantolactone, tocopherol.

Other information

  • Protect this product from excessive heat and direct sun.

Package Labeling:

label2

SPF 50 UVA/UVB 
ensulizole, oxybenzone, avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51191-3015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PPG-12 (UNII: L63N6V755Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TROMETHAMINE (UNII: 023C2WHX2V)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LEVOMENOL (UNII: 24WE03BX2T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
EDETATE SODIUM (UNII: MP1J8420LU)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PANTOLACTONE (UNII: J288D7O0JS)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51191-3015-150 g in 1 TUBE; Type 0: Not a Combination Product04/15/201304/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/15/201304/30/2024
Labeler - MULTALER ET CIE S.A.S. (509613345)
Registrant - MULTALER ET CIE S.A.S. (509613345)

Revised: 7/2024
 
MULTALER ET CIE S.A.S.