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

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.

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Drug Facts

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

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. If product is swallowed, get medical help or contact a Poison Control Center right away

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 information

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

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.

image description

DRY OIL SPF 15 
avobenzone 1.5% homosalate 5% octocrylene 3.5% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-731
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone1.5 g  in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-731-05170 g in 1 CAN; Type 0: Not a Combination Product02/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/29/2016
Labeler - Top Care (006935977)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(36800-731) , label(36800-731)

Revised: 7/2018
Document Id: ea45adda-735f-4624-a1f4-fab79eddd1f8
Set id: 5df0cc44-ce0b-43af-81fc-6f70b7479c19
Version: 1
Effective Time: 20180718
 
Top Care