MINERAL SUNSCREEN SPF 30- zinc oxide lotion

MINERAL SUNSCREEN by

Drug Labeling and Warnings

MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Lee Indie & Co Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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 CONSULT A PHYSICIAN IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

Shake before use.

• Apply generously to skin 15 minutes before sun exposure.
• During sun exposure, reapply: After 40 minutes of swimming or sweating
• Immediately after towel drying
• At least every two hours

Sun Protection Measures Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. to 4 p.m.; wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor

INACTIVE INGREDIENTS

Water (aqua), Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Squalane, Dicapryl Carbonate, Cetearyl Olivate, Sorbitan Olivate, Glycerin, Shea Butter Cetyl Esters, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Diglycerin, Pinus Pinaster (Cluster Pine) Bark Extract, Punica Granatum (Pomegranate) Seed Oil, Phenethyl Alcohol, Pentylene Glycol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Panthenol, Xanthan Gum, Lauroyl Lysine

OTHER INFORMATION

Protect this product from excessive heat and direct sun. Store below 90°F (32°C).

QUESTIONS OR COMMENTS?

INDIELEE.COM

+1 (866) 488-1638 MON-FRI (9 A.M. - 5 P.M. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81545-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MARITIME PINE (UNII: 50JZ5Z98QY)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PROPANEDIOL (UNII: 5965N8W85T)
LAUROYL LYSINE (UNII: 113171Q70B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN OLIVATE (UNII: MDL271E3GR)
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
DIGLYCERIN (UNII: 3YC120743U)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81545-101-50	1 in 1 BOX	09/17/2021
1	NDC: 81545-101-10	100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/17/2021

Labeler - Lee Indie & Co Inc (117191089)