Label: DRY OIL SPF 15- avobenzone 1.5% homosalate 5% octocrylene 3.5% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-731-05 - Packager: Top Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 18, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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
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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
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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
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INGREDIENTS AND APPEARANCE
DRY OIL SPF 15
avobenzone 1.5% homosalate 5% octocrylene 3.5% sprayProduct 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)
