SPF 50 MINERAL SUNSCREEN BABYGANICS- titanium dioxide and zinc oxide lotion
SPF 50 MINERAL SUNSCREEN BKIDS- titanium dioxide and zinc oxide lotion
KAS Direct LLC dba BabyGanics

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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SPF 50 Mineral Sunscreen

Drug Facts

Active ingredients

Titanium dioxide 3%, 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.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
children under 6 months of age: ask a doctor
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 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- sleeved shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

water, ethylhexyl palmitate, butyloctyl salicylate, caprylic/capric triglyceride, trimethylpentanediol/adipic acid/glycerin crosspolymer, cetearyl olivate, glycerin, sorbitan olivate, tocopheryl acetate, phenoxyethanol, cetearyl alcohol, cetearyl glucoside, propanediol, alumina, xanthan gum, jojoba esters, 1,2-hexanediol, bisabolol, helianthus annuus (sunflower) seed oil1, solanum lycopersicum (tomato) seed oil, lecithin, polyhydroxystearic acid, caprylhydroxamic acid, citric acid, isopropyl myristate, isostearic acid, polyglyceryl-3 polyricinoleate, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil

1: Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic • *Learn about these and all our ingredients and the choices we make at babyganics.com/products

dist. by KAS Direct, LLC
san francisco, ca 94111

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label - 59062-1001

non
allergenic

tear
free

babyganics®

SPF 50
mineral
sunscreen

pediatrician tested

broad spectrum SPF 50
water resistant (80 minutes)

made without oxybenzone, octinoxate,
parabens, fragrance, nano-particles

Discover which of our ingredients are
certified organic on the back panel.

2 FL OZ (59 mL)

Principal Display Panel - 59 mL Tube Label - 59062-1001

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label - 59062-1101

tear
free

kids
by babyganics®

easy rub-in

SPF 50
mineral
sunscreen

dermatologist tested

broad spectrum SPF 50
water & sweat resistant (80 minutes)

made without oxybenzone,
octinoxate, parabens, fragrance

Discover which of our ingredients are
certified organic on the back panel.

2 FL OZ (59 mL)

Principal Display Panel - 59 mL Tube Label - 59062-1101

SPF 50 MINERAL SUNSCREEN BABYGANICS
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59062-1001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	31.6 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Ethylhexyl Palmitate (UNII: 2865993309)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
Cetearyl Olivate (UNII: 58B69Q84JO)
GLYCERIN (UNII: PDC6A3C0OX)
Sorbitan Olivate (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Propanediol (UNII: 5965N8W85T)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
1,2-Hexanediol (UNII: TR046Y3K1G)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOMATO SEED OIL (UNII: 7N87T9C06T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Isostearic Acid (UNII: X33R8U0062)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
Nigella Sativa Seed Oil (UNII: CS4U38E731)
RASPBERRY SEED OIL (UNII: 9S8867952A)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59062-1001-2	59 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2021
2	NDC:59062-1001-6	177 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2021
3	NDC:59062-1001-8	226 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2021

SPF 50 MINERAL SUNSCREEN BKIDS
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59062-1101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	31.6 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Ethylhexyl Palmitate (UNII: 2865993309)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
Cetearyl Olivate (UNII: 58B69Q84JO)
GLYCERIN (UNII: PDC6A3C0OX)
Sorbitan Olivate (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Propanediol (UNII: 5965N8W85T)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
1,2-Hexanediol (UNII: TR046Y3K1G)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOMATO SEED OIL (UNII: 7N87T9C06T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Isostearic Acid (UNII: X33R8U0062)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
Nigella Sativa Seed Oil (UNII: CS4U38E731)
RASPBERRY SEED OIL (UNII: 9S8867952A)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59062-1101-2	59 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2021
2	NDC:59062-1101-6	177 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2021

Labeler - KAS Direct LLC dba BabyGanics (002764605)

Name	Address	ID/FEI	Business Operations
Establishment
Autumn Harp		064187883	MANUFACTURE(59062-1001, 59062-1101) , LABEL(59062-1001, 59062-1101)

Revised: 2/2021

Document Id: f3ca0977-4121-4da8-9a14-e4fcdd2e932d

Set id: 5453cd31-e70b-4f6c-81ce-206b960a54bc

Version: 1

Effective Time: 20210222

KAS Direct LLC dba BabyGanics