SMART CARE MINERAL-ENHANCED SUNSCREEN SPF 50- zinc oxide lotion

Smart Care Mineral-Enhanced SUNSCREEN SPF 50 by

Drug Labeling and Warnings

Smart Care Mineral-Enhanced SUNSCREEN SPF 50 by is a Otc medication manufactured, distributed, or labeled by Ashtel Studios, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Drug Facts

​Active ingredients

Zinc Oxide 19%

​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. to 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses

​Other information

protect this product from excessive heat and direct sun
may stain or damage some fabrics, materials or surfaces

​​Inactive ingredients

Aqua (Water), Mineral Oil, Cera Alba (White Beeswax), White Petrolatum, Microcrystalline Wax, Sorbitan Sesquioleate, Titanium Dioxide, Dimethicone, PEG-30 Dipolyhydroxystearate, Calendula Officinalis Flower Oil, Magnesium Sulfate, Phenoxyethanol, Ethylhexylglycerin, Fragrance, Citric Acid, Magnesium Stearate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aluminium Stearate, Aloe Barbadensis Leaf Juice

​Questions or comments?

Call toll free ​1-877-274-8358

SPL UNCLASSIFIED SECTION

UVA/UVB PROTECTION

BROAD SPECTRUM

Water Resistant (80 Minutes)

DESIGNED IN U.S.A. MADE IN INDIA

Smart Care®
WWW.SMARTCAREUS.COM
1-909-434-0911 INTERNATIONAL
PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CA 91761

Packaging

INGREDIENTS AND APPEARANCE

SMART CARE MINERAL-ENHANCED SUNSCREEN SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-269
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
WHITE WAX (UNII: 7G1J5DA97F)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-269-01	170 g in 1 TUBE; Type 0: Not a Combination Product	11/24/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/24/2025

Labeler - Ashtel Studios, Inc. (148689180)