MINERAL UNSEEN SUNSCREEN SPF 40- titanium dioxide, zinc oxide lotion

Mineral Unseen Sunscreen SPF 40 by

Drug Labeling and Warnings

Mineral Unseen Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Titanium Dioxide 1.33%, Zinc Oxide 17.68%

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

DOSAGE & ADMINISTRATION

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply (will vary depending on WR)

after XX minutes of swimming or sweating

Immediately after towel drying

at least 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 value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.- 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: DIMETHICONE, DIMETHICONE CROSSPOLLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHYL DIHYDROABIETATE, POLYHYDROXYSTEARIC ACID, C9-12 ALKANE, GLYCERIN, ETHYLHEXYLGLYCERIN, WATER (AQUA), COCO-CAPRYLATE/CAPRATE, SILICA, STEARIC ACID, HEDYCHIUM CORONARIUM ROOT EXTRACT, PROPANEDIOL, SCHIZANDRA CHINENSIS FRUIT EXTRACT, TOCOPHEROL

PRINCIPAL DISPLAY PANEL

Mineral Unseen Sunscreen SPF 40

Broad Spectrum Sunscreen

1.7 fl. oz. / 50 ml

Mineral Unseen Sunscreen SPF 40

15 mL

Mineral Unseen Sunscreen SPF 40

10 ml

Mineral Unseen Sunscreen SPF 40

1.5 ml

INGREDIENTS AND APPEARANCE

MINERAL UNSEEN SUNSCREEN SPF 40 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-623
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.68 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.33 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
C9-12 ALKANE (UNII: 7J5R5W72QM)
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-623-02	1 in 1 BOX	10/23/2023
1	NDC: 75936-623-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 75936-623-03	15 mL in 1 TUBE; Type 0: Not a Combination Product	10/23/2023
3	NDC: 75936-623-04	10 mL in 1 TUBE; Type 0: Not a Combination Product	10/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/23/2023

Labeler - Supergoop, LLC (117061743)