OTC Medication Information: B-AGELESS Tinted Mineral Broad Spectrum SPF30 Sunscreen

B-AGELESS TINTED MINERAL BROAD SPECTRUM SPF30 SUNSCREEN- titanium dioxide and zinc oxide cream
JP Beauty Supply 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.

DRUG FACTS:

ACTIVE INGREDIENTS

Titanium Dioxide 7.75%, Zinc Oxide 10.0%.

Purpose

Sunscreen

USES

Helps prevent sunburn.

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.

DIRECTIONS

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: Ask a doctor. 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.

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Aluminum Stearate, Carthamus Tinctorius Oleosomes, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Polygonum Aviculare Extract, Tocopheryl Acetate, Perilla Frutescens Extract, Vitis Vinifera Fruit Cell Extract, Lepidium Sativum Sprout Extract, Squalane, Cetearyl Alcohol, Isononyl Isononanoate, Coco-Glucoside, Pentylene Glycol, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Sucrose Stearate, Phenethyl Alcohol, Tetrahexyldecyl Ascorbate, Glyceryl Caprylate, Ethylene/Propylene/Styrene Copolymer, Sorbitan Oleate, Polyglyceryl-2 Caprate, Propanediol, Alumina, Arachidyl Alcohol, Iron Oxides (CI 77492, CI 77491, CI 77499).

OTHER INFORMATION

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

Simply Made by Science B-AGELESS Tinted Mineral Broad Spectrum SPF30 Sunscreen

Simply Made by Science B-AGELESS Tinted Mineral Broad Spectrum SPF30 ​Sunscreen
(click image for full-size original)

B-AGELESS
Tinted Mineral
Broad Spectrum SPF30
​Sunscreen

B-AGELESS TINTED MINERAL BROAD SPECTRUM SPF30 SUNSCREEN
titanium dioxide and zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82159-0624
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 7.75 g in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
BUTYLOCTYL SALICYLATE
GLYCERIN
DIMETHICONE
COCOYL CAPRYLOCAPRATE
ALUMINUM STEARATE
CARTHAMUS TINCTORIUS SEED OLEOSOMES
ALOE VERA LEAF
POLYGONUM AVICULARE TOP
.ALPHA.-TOCOPHEROL ACETATE
GARDEN CRESS SPROUT
SQUALANE
CETOSTEARYL ALCOHOL
ISONONYL ISONONANOATE
COCO GLUCOSIDE
PENTYLENE GLYCOL
DOCOSANOL
XANTHAN GUM
TRIETHOXYCAPRYLYLSILANE
ARACHIDYL GLUCOSIDE
JOJOBA OIL
STEARIC ACID
SUCROSE STEARATE
PHENYLETHYL ALCOHOL
TETRAHEXYLDECYL ASCORBATE
GLYCERYL MONOCAPRYLATE
SORBITAN MONOOLEATE
POLYGLYCERYL-2 CAPRATE
PROPANEDIOL
ALUMINUM OXIDE
ARACHIDYL ALCOHOL
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82159-0624-1 240 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/12/2021
Labeler — JP Beauty Supply Inc. (118030137)

Revised: 08/2021 JP Beauty Supply 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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