SPF 50 SUNSCREEN STICK- zinc oxide stick 
OraLabs

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 ingredient

Zinc Oxide….20.0%

Purpose

Sunscreen

Keep Out of Reach of Children

If swallowed; get medical help or contact a Poison Control Center right away.

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. 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.

Directions

Apply liberally 15 minutes before sun exposure. 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 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-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Extract, Behenyl Behenate, Shea Butter, Caprylic/Capric Triglyceride, Coconut Oil, Candelilla Wax, Sunflower Oil, Sunflower Wax, Polyhydroxystearic Acid, Castor Oil, Jojoba Oil, Squalane, Cocoa Butter, Tocopherol (Vitamin E).

Package/Label Principal Display Panel

OTC Drug Label
SPF 50 SUNSCREEN STICK 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-178
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L) 395 mg  in 1 g
WHITE WAX (UNII: 7G1J5DA97F) 162 mg  in 1 g
COCOA BUTTER (UNII: 512OYT1CRR) 57 mg  in 1 g
SUNFLOWER OIL (UNII: 3W1JG795YI) 64 mg  in 1 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63645-178-0514 g in 1 CONTAINER; Type 0: Not a Combination Product02/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/24/2020
Labeler - OraLabs (801824756)
Registrant - OraLabs (801824756)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(63645-178) , LABEL(63645-178)

Revised: 11/2022
Document Id: 91bd6dbc-064a-4636-b334-0fc6431e3ec4
Set id: 096abb78-28ba-4bb6-89f6-927296d69314
Version: 2
Effective Time: 20221103
 
OraLabs