ALL HOURS FOUNDATION SPF 20- octinoxate cream

All hours Foundation SPF 20 by

Drug Labeling and Warnings

All hours Foundation SPF 20 by is a Otc medication manufactured, distributed, or labeled by BPS 60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 3%

Purpose

Sunscreen

Use

• 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

Flammable until dry. Avoid fire, flame and heat during application.

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:

• shake well before use

● apply generously 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, cyclohexasiloxane, alcohol denat. isododecane, acrylates/polytrimethylsiloxymethacrylate copolymer, butylene glycol, glycerin, polymethylsilsesquioxane, cetyl PEG/PPG-10/1 dimethicone, synthetic fluorphlogopite, isohexadecane, polyglyceryl-4 isostearate, magnesium sulfate, disodium stearoyl glutamate, silica, silylate, aluminum hydroxide, butyrospermum parkii (shea) seedcake extract, hydroxyethylcellulose, BHT phenoxyethanol, sodium citrate, benzyl alcohol, linalool, citric acid, potassium sorbate, pentaerythrityl tetra-di-butyl hydroxyhydrocinnamate, biotin; may contain: titanium dioxide, iron oxides

Package Labeling:

INGREDIENTS AND APPEARANCE

ALL HOURS FOUNDATION SPF 20 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70581-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALCOHOL (UNII: 3K9958V90M)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BIOTIN (UNII: 6SO6U10H04)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70581-013-00	1 in 1 CARTON	12/25/2017
1		125 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/25/2017

Labeler - BPS 60 (272259304)