DRY OIL SPF 15- avobenzone 1.5% homosalate 5% octocrylene 3.5% spray

Dry Oil SPF 15 by

Drug Labeling and Warnings

Dry Oil SPF 15 by is a Otc medication manufactured, distributed, or labeled by Top Care, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                               Purpose
Avobenzone 1.5%..............................Sunscreen
Homosalate 5%.................................Sunscreen
Octocrylene 3.5%..............................Sunscreen

INDICATIONS & USAGE

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 sun

WARNINGS

Warnings
For external use only
Flammable: Do not use near heat, flame, or
while smoking.
Do not use on damaged or broken skin
When using this product Keep out of eyes.
Rinse eyes with water to remove. Keep away
from face to avoid breathing it Do not
puncture or incinerate. Contents under pressure.
Do not store at temperatures above 120ºF.
Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

Spray liberally and spread
evenly by hand 15 minutes before sun
exposure. Reapply: after 80 minutes of
swimming or sweating immediately after
towel drying at least every 2 hours. Hold
container 4 to 6 inches from the skin to apply.
Do not spray directly into face. Spray on
hands then apply to face. Do not apply in
windy conditions. Use in a well-ventilated
area. 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 time in
the sun, especially from 10 a.m. – 2 p.m. wear
long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor.

OTHER SAFETY INFORMATION

Other information

protect this
product from excessive heat and direct sun.
may stain fabrics.

INACTIVE INGREDIENT

Inactive ingredients
Acrylates/Dimethicone
Copolymer, Acrylates/
Octylacrylamide
Copolymer, Alcohol
Denat., Argania Spinosa
Kernel Oil, Ascorbyl
Palmitate, Cocos
Nucifera (Coconut) Oil,
Cyclopentasiloxane,
Dimethicone, Fragrance,
PPG-5-Ceteth-20,
Passiflora Edulis Seed
Oil, Polyester-8,
Tocopheryl Acetate,
Trisiloxane.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRY OIL SPF 15 
avobenzone 1.5% homosalate 5% octocrylene 3.5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-731
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	1.5 g  in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ARGAN OIL (UNII: 4V59G5UW9X)
Ascorbyl Palmitate (UNII: QN83US2B0N)
COCONUT OIL (UNII: Q9L0O73W7L)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)
Passiflora Edulis Seed Oil (UNII: F3VOA31UHQ)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Trisiloxane (UNII: 9G1ZW13R0G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-731-05	170 g in 1 CAN; Type 0: Not a Combination Product	02/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/29/2016

Labeler - Top Care (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-731) , label(36800-731)