ALL HOURS PRIMER SPF 18- octinoxate cream

All Hours Primer SPF 18 by

Drug Labeling and Warnings

All Hours Primer SPF 18 by is a Otc medication manufactured, distributed, or labeled by BPS 60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Octinoxate 6.5%

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

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 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, dimethicone, isododecane, alcohol, trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, titanium dioxide, perlite, nylon-12, lauryl methacrylate/glycol dimethacrylate crosspolymer, HDI/trimethylol hexyllactone crosspolymer, bismuth oxychloride, BIS-PEG/PPG-14/14 dimethicone, magnesium sulfate, silica silylate, phenoxyethanol, disteardimonium hectorite, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, hydrogen dimethicone, tocopherol, propylene glycol, silica, iron oxides, BHT, synthetic fluorphlogopite, rosa centifolia flower extract, disodium stearoyl glutamate

Package Labeling:

INGREDIENTS AND APPEARANCE

ALL HOURS PRIMER SPF 18 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70581-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PERLITE (UNII: 0SG101ZGK9)
NYLON-12 (UNII: 446U8J075B)
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE (UNII: 230K0823CE)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70581-018-00	1 in 1 CARTON	12/25/2017
1		40 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)