BABO SPF 30 SHEER ZINC SUNSCREEN- mineral sunscreen spray 
Babo Botanicals, Inc.

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.

----------

8097 Babo SPF 30 Sheer Zinc Sunscreen

Active Ingredient(s)

Zinc Oxide 12%

Purpose

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 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. Rinse with water to remove.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

  • rash occurs.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Shake well before use • Hold container 4 to 6 inches from the skin to apply • Apply liberally 15 minutes before sun exposure • Do not spray directly into face • Do not spray in windy condition • Use in 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 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

Inactive ingredients

Water (Aqua), Butyloctyl Salicylate, Bentonite, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Methyl Dihydroabietate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Glycerin, Coco-Glucoside, Caprylyl Glycol, Caprylhydroxamic Acid, Cetearyl Alcohol.

Questions and comments?

Call 1-800-422-2987 Mon - Fri 9:00AM - 5:00PM EST

Package Label - Principal Display Panel

1

BABO SPF 30 SHEER ZINC SUNSCREEN 
mineral sunscreen spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8097
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.222 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHAMOMILE (UNII: FGL3685T2X)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
BENTONITE (UNII: A3N5ZCN45C)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)  
COCO GLUCOSIDE (UNII: ICS790225B)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79265-8097-6177 mL in 1 CAN; Type 0: Not a Combination Product11/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02011/01/2020
Labeler - Babo Botanicals, Inc. (058258734)

Revised: 11/2022
Document Id: edfe52ae-c7e7-2ed6-e053-2995a90aa58b
Set id: b13167ae-4f81-56db-e053-2a95a90ad72f
Version: 5
Effective Time: 20221121
 
Babo Botanicals, Inc.