Daily Facial Moisturizer: Package Insert and Label Information

DAILY FACIAL MOISTURIZER- octinoxate, octisalate and avobenzone lotion
BIG LOTS

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.

Active ingredients

Octinoxate 7.5%

Octisalate 5.0%

Avobenzone 3.0%

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

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 a Poison Control Center right away.

Directions

  • 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 the 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 from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

water, diisopropyl adipate, cyclomethicone, glycerin, undecylcrylene dimethicone, glyceryl stearate, PET-100 stearate, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, tocopyeryl acetate, carbomer, disodium EDTA, trietanoolamine, potassium sorbate

*This product is not manufactured or distributed by Galderma Laboratories, LP, distributor of Cetaphil Daily Facial Moistrizer SPF 15

Made in the USA with US and foreign components

May stain or damage some fabric or surfaces.

Manufactured for Big Lots by: Vi-Jon, Inc.

8515 Page Avenue St. Louis, MO 63114

995.001/995AB

principal display panel

Sound Body

Compare to Cetaphil Daily Facial Moisturizer*

Daily Facial Moisturizer

BROAD SPECTRUM SPF 15 SUNSCREEN

Non-comedogenic

UVA/UVB protection

Helps revent sunburn

Fragrance Free

Lightweight & non-greasy

4.8 FL OZ (141 mL)

image description
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DAILY FACIAL MOISTURIZER
octinoxate, octisalate, avobenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-995
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 76.5 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 51.0 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 30.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIISOPROPYL ADIPATE
CYCLOMETHICONE
GLYCERIN
UNDECYLCRYLENE DIMETHICONE (10000 MW)
GLYCERYL STEARATE SE
PEG-100 STEARATE
METHYL METHACRYLATE
PHENOXYETHANOL
BENZYL ALCOHOL
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
TOCOPHEROL
CARBOMER 940
EDETATE DISODIUM
TRIETHANOLAMINE LACTATE
POTASSIUM SORBATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50594-995-26 1 BOTTLE, PLASTIC in 1 PACKAGE contains a BOTTLE, PLASTIC
1 141 mL in 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (50594-995-26)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/25/2017
Labeler — BIG LOTS (017885351)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (50594-995)

Revised: 01/2022 BIG LOTS

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