TAOS AER - MINERAL SUNSCREEN SPF 30 (81883-101) - DELIST

MINERAL SUNSCREEN by

Drug Labeling and Warnings

MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by TAOS AER LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL SUNSCREEN SPF 30- zinc oxide lotion 
TAOS AER LLC

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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TAOS AER - MINERAL SUNSCREEN SPF 30 (81883-101) - DELIST

ACTIVE INGREDIENT

ZINC OXIDE 20%

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN
• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURE (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 POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• SHAKE WELL. APPLY AT LEAST 1 PUMP TO FACE. APPLY ADDITIONAL PUMPS TO NECK AND CHEST - AREAS THAT ARE OFTEN IGNORED.
• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
• REAPPLY EVERY 2 HOURS
• 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
• LIMIT TIME IN THE SUN, ESPECIALLY BETWEEN 10 A.M. AND 2 P.M.
• WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES
• CHILDREN UNDER 6 MONTHS: CONSULT A PHYSICIAN

INACTIVE INGREDIENTS

WATER (AQUA), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, OLEA EUROPEA (OLIVE FRUIT) OIL, 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, VETIVERIA ZIZANOIDES (VETIVER) ROOT OIL, JUNIPERUS VIRGINIANA (CEDAR) WOOD OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, SALVIA OFFICINALIS (SAGE) OIL, LIMONENE-D, LINALOOL

OTHER INFORMATION

PROTECT THIS PRODUCT AWAY FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT. STORE BELOW 90°F (32°C). MAY STAIN SOME FABRICS.

QUESTIONS OR COMMENTS?

VISIT: WWW.TAOSAER.COM

CALL: (888)-751-3663 MONDAY - FRIDAY (9 A.M. - 5 P.M. cT)

MINERAL SUNSCREEN  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81883-101
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
OLIVE OIL (UNII: 6UYK2W1W1E)
SAGE OIL (UNII: U27K0H1H2O)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)
VETIVER OIL (UNII: 9M9P32M01L)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
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)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIGLYCERIN (UNII: 3YC120743U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81883-101-11	120 mL in 1 TUBE; Type 0: Not a Combination Product	09/18/2021	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/18/2021	12/31/2022

Labeler - TAOS AER LLC (118053357)

Revised: 1/2023

Document Id: f17830c7-fe98-4a6a-e053-2995a90affc7

34390-5

Set id: cc4ac201-c71d-7acd-e053-2995a90a5bd2

Version: 4

Effective Time: 20230104

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