BABO SPF 30 CLEAR ZINC FRAGRANCE FREE- mineral sunscreen lotion 
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.

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79265-8077 Babo SPF 30 Clear Zinc, Fragrance Free Sunscreen Lotion

79265-8077 SPF 30 Clear Zinc, Fragrance Free Sunscreen Lotion

79265-8077-3 3 fl. oz.

This is an OTC Sunscreen product manufactured pursuant to the sunscreen final monograph, Part352.

Active Ingredients

Zinc Oxide 16.0%

Purpose

Purpose: Sunscreen

Stop use and ask doctor

Stop use and ask doctor if rash occurs.

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 doctor if rash occurs. • Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.

Keep Out of Reach of Children

Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.

Directions

Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.

Sun Protection Measures

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

Inactive Ingredients

ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BISABOLOL*, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CELLULOSE GUM, CETEARYL ALCOHOL, CETYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYL DIHYDROABIETATE, MICROCRYSTAL-LINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, POLYHYDROXYSTEARIC ACID, PUERARIA LOBATA ROOT EXTRACT*, SODIUM GLUCONATE, SODIUM HYALURONATE, SODIUM STEAROYL GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, WATER (AQUA). *Certified Organic Ingredients

Other Information

Protect this product from excessive heat and direct sun

Questions and comments?

Questions and comments?Call 1-877-537-BABO

Information Panel

Dist: by Babo Botanicals, Inc.

14 Harwood Court, Scarsdale, NY 10583

1.877.537.BABO www.babobotanicals.com

MADE IN THE USA with US & imported materials.

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.

Principal Display Panel

Babo Botanicals

Clear Zinc Sunscreen

Broad Spectrum SPF 30

Hypoallergenic

Fragrance Free

For Babies, Kids & Grown Ups Too!

3 fl oz / 89 ml

Principal Display Panel

BABO SPF 30 CLEAR ZINC FRAGRANCE FREE 
mineral sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8077
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 50.032 mL  in 100 mL
COCONUT OIL (UNII: Q9L0O73W7L) 5 mL  in 100 mL
SUNFLOWER OIL (UNII: 3W1JG795YI) 5.1 mL  in 100 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.2 mL  in 100 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1.3 mL  in 100 mL
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) 0.306 mL  in 100 mL
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) 0.99 mL  in 100 mL
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 0.25 mL  in 100 mL
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) 3 mL  in 100 mL
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.002 mL  in 100 mL
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) 0.002 mL  in 100 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.002 mL  in 100 mL
CHAMOMILE (UNII: FGL3685T2X) 0.002 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.2 mL  in 100 mL
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) 1.3 mL  in 100 mL
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) 0.14 mL  in 100 mL
COCOA BUTTER (UNII: 512OYT1CRR) 0.8 mL  in 100 mL
DOCOSANOL (UNII: 9G1OE216XY) 0.504 mL  in 100 mL
LEVOMENOL (UNII: 24WE03BX2T) 0.3 mL  in 100 mL
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.002 mL  in 100 mL
TOCOPHEROL (UNII: R0ZB2556P8) 0.75 mL  in 100 mL
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 1.06 mL  in 100 mL
SODIUM GLUCONATE (UNII: R6Q3791S76) 0.2 mL  in 100 mL
SHEA BUTTER (UNII: K49155WL9Y) 2.1 mL  in 100 mL
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) 0.15 mL  in 100 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.7 mL  in 100 mL
SAFFLOWER OIL (UNII: 65UEH262IS) 3 mL  in 100 mL
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 5 mL  in 100 mL
CETYL ALCOHOL (UNII: 936JST6JCN) 0.75 mL  in 100 mL
COCO GLUCOSIDE (UNII: ICS790225B) 0.7 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.158 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79265-8077-389 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/2020
Labeler - Babo Botanicals, Inc. (058258734)

Revised: 1/2022
Document Id: d6e49ade-65e7-49ae-e053-2995a90af74b
Set id: b3e40cb0-dbfd-955c-e053-2995a90af848
Version: 4
Effective Time: 20220131
 
Babo Botanicals, Inc.