OTC Medication Information: MINERAL SUNSCREEN SPF 30

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.

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. 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)

0-LBL (PDP)_Mineral Sunscreen
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MINERAL SUNSCREEN SPF 30
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81545-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 20 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
MARITIME PINE
POMEGRANATE SEED OIL
ALOE VERA LEAF
PANTHENOL
XANTHAN GUM
PHENYLETHYL ALCOHOL
PENTYLENE GLYCOL
PROPANEDIOL
LAUROYL LYSINE
MEDIUM-CHAIN TRIGLYCERIDES
SORBITAN OLIVATE
WATER
SUNFLOWER OIL
GLYCERIN
SQUALANE
DICAPRYLYL CARBONATE
CETEARYL OLIVATE
DIGLYCERIN
SHEA BUTTER ETHYL ESTERS
SORBITAN SESQUIOLEATE
POLYHYDROXYSTEARIC ACID (2300 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81545-101-50 1 TUBE in 1 BOX contains a TUBE (81545-101-10)
1 NDC:81545-101-10 100 mL in 1 TUBE This package is contained within the BOX (81545-101-50)
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)

Revised: 09/2021 Lee Indie & Co Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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