Label: HURLEY BROAD SPECTRUM SPF- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 13630-0178-4
- Packager: Prime Packaging, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Warnings
-
Directions
shake well before use
apply liberally 15 minutes before sun exposure and rub into skin
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
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
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
- Inactive Ingredients
- Other Information
- Questions or Comments?
- Hurley Reef Friendly Sunscreen Spray Broad Spectrum SPF 30
-
INGREDIENTS AND APPEARANCE
HURLEY BROAD SPECTRUM SPF
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0178 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) COCONUT OIL (UNII: Q9L0O73W7L) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color yellow (Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0178-4 156 g in 1 CAN; Type 0: Not a Combination Product 02/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/24/2020 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0178) , label(13630-0178) , analysis(13630-0178) , pack(13630-0178) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0178) , pack(13630-0178)