SPF 50 MINERAL SUNSCREEN BABYGANICS- titanium dioxide and zinc oxide lotion SPF 50 MINERAL SUNSCREEN BKIDS- titanium dioxide and zinc oxide lotion

SPF 50 Mineral Sunscreen by

Drug Labeling and Warnings

SPF 50 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics, Autumn Harp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 - 59062-1101

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2021

Labeler - KAS Direct LLC dba BabyGanics (002764605)

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