Skin Activator Day SPF 15

Dosage form: lotion
Ingredients: Octinoxate 0.0742g in 1mL, Octisalate 0.0495g in 1mL, Avobenzone 0.0198g in 1mL
Labeler: Herbalife International of America, Inc.
NDC Code: 51785-086

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.

Drug Facts


ACTIVE INGREDIENTS
Octinoxate (7.5%)
Octisalate (5%)
Avobenzone (2%)

USES

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions),  may decrease the risk of skin cancer and early  skin aging caused by the sun.

DIRECTIONS

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

WARNINGS
For external use only.

Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Do not use on damaged or broken skin.


INACTIVE INGREDIENTS
Water
Pentylene glycol
Dimethicone
Arachidyl alcohol
Glyceryl stearate
Peg-100 stearate
Butylene glycol
Glycerin
Isododecane
Glucosamine hydrochloride
Algae extract
Yeast extract
Urea
Tocopherol acetate 
Retinyl palmitate
Duboisia leichardtii leaf extract
Geranium maculatum root
Arnica montana flower extract
Camellia sinensis leaf extract
Squalane
Potato starch modified
Biosaccharide gum-1 
Behenyl alcohol
Arachidyl glucoside 
Polyacrylamide
C13-14 isoparaffin
Laureth-7
Fragrance (parfum)
Disodium edta
Sodium dehydroacetate
Phenoxyethanol
Methylparaben
Ethylparaben
Propylparaben
Butylparaben
Isobutylparaben






SKIN ACTIVATOR DAY  SPF 15
octinoxate, octisalate and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51785-086
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.0742 g  in 1 mL
Octisalate (Octisalate) Octisalate0.0495 g  in 1 mL
Avobenzone (Avobenzone) Avobenzone0.0198 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PENTYLENE GLYCOL 
DIMETHICONE 
ARACHIDYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
BUTYLENE GLYCOL 
GLYCERIN 
ISODODECANE 
GLUCOSAMINE HYDROCHLORIDE 
LAMINARIA DIGITATA 
YEAST 
UREA 
ALPHA-TOCOPHEROL ACETATE 
VITAMIN A PALMITATE 
DUBOISIA LEICHHARDTII LEAF 
GERANIUM MACULATUM ROOT 
ARNICA MONTANA FLOWER 
GREEN TEA LEAF 
SQUALANE 
STARCH, POTATO 
BIOSACCHARIDE GUM-1 
DOCOSANOL 
ARACHIDYL GLUCOSIDE 
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) 
C13-14 ISOPARAFFIN 
LAURETH-7 
EDETATE DISODIUM 
SODIUM DEHYDROACETATE 
PHENOXYETHANOL 
METHYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
ISOBUTYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:51785-086-201 TUBE (TUBE) in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/21/2011
Labeler - Herbalife International of America, Inc. (873035968)

Revised: 07/2012
 
Herbalife International of America, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)