MINERAL SUNSCREEN SPF 30- zinc oxide lotion 
Lee Indie & Co Inc

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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INDIE LEE - MINERAL SUNSCREEN SPF 30 (81545-101)

ACTIVE INGREDIENT

ZINC OXIDE 20%

PURPOSE

SUNSCREEN

USES

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. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

Shake before use.

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)

0-LBL (PDP)_Mineral Sunscreen

0-LBL (back)_Mineral Sunscreen

MINERAL SUNSCREEN  SPF 30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81545-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81545-101-501 in 1 BOX09/17/2021
1NDC:81545-101-10100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/17/2021
Labeler - Lee Indie & Co Inc (117191089)

Revised: 1/2023
Document Id: f1f190da-554c-55cb-e053-2a95a90a2871
Set id: cc37a6e8-3ce3-5eb4-e053-2995a90a217a
Version: 5
Effective Time: 20230110
 
Lee Indie & Co Inc