OTC Medication Information: Mineral Sunscreen SPF-30

MINERAL SUNSCREEN SPF-30- titanium dioxide and zinc oxide liquid
NEWCO LLC

Drug Facts

Active Ingredient

Titanium Dioxide 6.00% Zinc Oxide 6.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • 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 your doctor

if a rash or irritation occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: Ask a doctor. • After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.
Reapply: Sun Protection Measures:

Other Information

• Protect the product in this container from excessive heat and direct sun.

Other Ingredients:

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, *Carthamus Tinctorius (Safflower) Oil, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate Citrate, *Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.

*Denotes organic ingredients

Package Labeling:

Bottle
(click image for full-size original)

MINERAL SUNSCREEN SPF-30
titanium dioxide, zinc oxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:83387-399
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 60 mg in 1 mL
ZINC OXIDE (ZINC CATION) ZINC CATION 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
WATER
GREEN TEA LEAF
MEDIUM-CHAIN TRIGLYCERIDES
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE
SAFFLOWER
ETHYLHEXYLGLYCERIN
GLYCERIN
GLYCERYL STEARATE CITRATE
HELIANTHUS ANNUUS FLOWERING TOP
PHENOXYETHANOL
PUNICA GRANATUM ROOT BARK
STEARIC ACID
TETRASODIUM GLUTAMATE DIACETATE
COCOA
TOCOPHEROL
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:83387-399-00 177 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 04/17/2023
Labeler — NEWCO LLC (117874606)

Revised: 11/2023 NEWCO LLC

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.

Terms of Use | Copyright © 2024. All Rights Reserved.