PRIMER BROAD SPECTRUM SUNSCREEN- avobenzone, octinoxate, octisalate, octocrylene cream 
Black Up sas

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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Primer Broad Spectrum Sunscreen

Drug Facts

Active ingredients

Avobenzone 2.00%

Octinoxate 4.50%

Octisalate 3.00%

Octocrylene 4.00%

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 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For sunscreen use
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

WATER, BUTYLOCTYL SALICYLATE, POLYSILICONE-11, DIMETHICONOL BEHENATE, TRIBEHENIN PEG-20 ESTERS, POLYMETHYLSILSESQUIOXANE, GLYCERIN, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, MAGNESIUM ALUMINUM SILICATE, DIMETHICONE, SODIUM LAURYL GLUCOSE CARBOXYLATE, HYDROXYACETOPHENONE, LAURYL GLUCOSIDE, CETEARYL ISONONANOATE, TOCOPHERYL ACETATE, XANTHAN GUM, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, CETEARETH-20, BHT, DISODIUM EDTA, GLYCERYL STEARATE, ETHYLHEXYLGLYCERIN, LAURETH-12, CETEARETH-12, CETYL PALMITATE, SODIUM HYALURONATE, HYDROLYZED ROCKET (ERUCA SATIVA) LEAF, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE, BENZYL SALICYLATE, CITRONELLOL, LIMONENE, ALPHA ISOMETHYL IONONE, HEXYL CINNAMAL, BUTYLPHENYL MET HYLPROPIONAL, LINALOOL, FRAGRANCE

Package Labeling:

JarCarton

PRIMER BROAD SPECTRUM SUNSCREEN 
avobenzone, octinoxate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70495-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE45 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LAURETH-12 (UNII: OAH19558U1)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ERUCA VESICARIA SUBSP. SATIVA LEAF (UNII: 578J4N893E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70495-021-301 in 1 BOX11/17/201608/01/2018
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/09/201608/01/2018
Labeler - Black Up sas (505251558)

Revised: 1/2018
Document Id: 630d9a3b-3a06-5c6e-e053-2991aa0a61bc
Set id: bd2e6e28-5135-470a-afa7-ee86c01f4115
Version: 7
Effective Time: 20180118
 
Black Up sas