BABYGANICS SHEER BLEND SPF50 MINERAL SUNSCREEN- zinc oxide lotion

Babyganics Sheer Blend SPF50 Mineral Sunscreen by

Drug Labeling and Warnings

Babyganics Sheer Blend SPF50 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics, APEX International MFG., LLC, Voyant Beauty, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

Zinc oxide 20%
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

butyloctyl salicylate, butyrospermum parkii (shea) butter1, caprylic/capric triglyceride, capryloyl glycine, caprylyl glycol, coco-caprylate, cocos nucifera (coconut) oil1, ethylhexylglycerin, glycerin1, helianthus annuus (sunflower) seed oil1, lsoamyl laurate, magnesium stearate, magnesium sulfate, nigella sativa seed oil1, polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyhydroxystearic acid, propanediol, rubus ldaeus (raspberry) seed oil, sodium phytate, solanum lycopersicum (tomato) seed oil, stearyl/octyldodecyl citrate crosspolymer, undecylenoyl glycine, vaccinium macrocarpon (cranberry) seed oil, water

1 Certified Organic Ingredient Unless otherwise specified, product not labeled as organic.

SPL UNCLASSIFIED SECTION

Dist. by KAS Direct, LLC
1525 Howe St., Racine, WI 53403

PRINCIPAL DISPLAY PANEL - 236 mL Tube Label

non
allergenic

blends in
& blocks
out

babyganics®

SHEER BLEND

SPF 50 mineral
sunscreen

fragrance free

tear free 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 back panel.

8 FL OZ (236 mL)

PRINCIPAL DISPLAY PANEL - 236 mL Tube Label

INGREDIENTS AND APPEARANCE

BABYGANICS SHEER BLEND SPF50 MINERAL SUNSCREEN
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-2202
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Coco-Caprylate (UNII: 4828G836N6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
Isoamyl laurate (UNII: M1SLX00M3M)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Shea Butter Ethyl Esters (UNII: V2CI786FPG)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Polyglyceryl-2 oleate (UNII: 5759J47SAM)
Polyglyceryl-2 stearate (UNII: 253MC0P0YV)
Propanediol (UNII: 5965N8W85T)
Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)
Undecylenoyl Glycine (UNII: 4D20464K2J)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
PHYTATE SODIUM (UNII: 88496G1ERL)
SUNFLOWER SEED (UNII: R9N3379M4Z)
TOMATO SEED OIL (UNII: 7N87T9C06T)
CRANBERRY SEED (UNII: 38ZFO1X2U7)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
Capryloyl Glycine (UNII: 8TY5YO42NJ)
Caprylyl Glycol (UNII: 00YIU5438U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 59062-2202-8	236 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2023
2	NDC: 59062-2202-3	89 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2023
3	NDC: 59062-2202-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	12/01/2023

Labeler - KAS Direct LLC dba BabyGanics (002764605)

Name	Address	ID/FEI	Business Operations
Establishment
APEX International MFG., LLC		079110793	MANUFACTURE(59062-2202)

Name	Address	ID/FEI	Business Operations
Establishment
Voyant Beauty, Inc.		253610042	MANUFACTURE(59062-2202)