OTC Medication Information: Solar Defense Tinted

SOLAR DEFENSE TINTED- titanium dioxide and zinc oxide cream
HydroPeptide LLC

Drug Facts

Active Ingredients

Titanium Dioxide (2.5%)

Zinc Oxide (6%)

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • If used as directed with other usn protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Warnings

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

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • 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 of age: Ask a doctor

Inactive Ingredients

1,2-Hexanediol, Acrylates/Ammonium Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Alpinia Galanga Extract, Alumina, Benzyl Benzoate, Benzyl Salicylate, Biotin, Boron Nitridem, Butylene Glycol, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Caprylyl Methicone, Cellulose Acetate, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Citral, Citric Acid Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Cyclophentasiloxane, Dimethicone , Disodium EDTA, Ethylhexyl Palmitate, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Hexyl Cinnamal, Hydrolyzed Yeast Protein, Hydroxyethyl Acylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Lilial, Limonene, Niacinamide, Panthenol, PEG-100 Stearate, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Propanediol, Propylene Glycol Stearate, Propylene Glycol, Pyridoxine HCl, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Thermus Thermophilus Ferment, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Water, Xanthan Gum

Other Information

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

Questions or comments?

Call 1.800.932.9873

Package Labeling:

Label3
(click image for full-size original)

SOLAR DEFENSE TINTED
titanium dioxide, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60934-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 25 mg in 1 mL
ZINC OXIDE (ZINC CATION) ZINC CATION 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
1,2-HEXANEDIOL
ALLANTOIN
ALOE VERA LEAF
ALUMINUM OXIDE
BENZYL BENZOATE
BENZYL SALICYLATE
BIOTIN
BORON NITRIDE
BUTYLENE GLYCOL
ALKYL (C12-15) BENZOATE
CALENDULA OFFICINALIS FLOWER
CAMELLIA OLEIFERA LEAF
CAPRYLYL GLYCOL
CAPRYLYL TRISILOXANE
CELLULOSE ACETATE
CETYL ALCOHOL
CHAMOMILE
CHLORPHENESIN
CITRAL
CUCUMBER
CYCLOMETHICONE
DIMETHICONE
EDETATE DISODIUM ANHYDROUS
ETHYLHEXYL PALMITATE
ACAI
GLYCERIN
GLYCERYL MONOCAPRYLATE
GLYCERYL MONOSTEARATE
.ALPHA.-HEXYLCINNAMALDEHYDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
BUTYLPHENYL METHYLPROPIONAL
LIMONENE, (+)-
NIACINAMIDE
PANTHENOL
PEG-100 STEARATE
PENTYLENE GLYCOL
POLYSORBATE 60
PROPANEDIOL
PROPYLENE GLYCOL MONOSTEARATE
PROPYLENE GLYCOL
PYRIDOXINE HYDROCHLORIDE
SODIUM CITRATE
HYALURONATE SODIUM
SODIUM PYRROLIDONE CARBOXYLATE
THERMUS THERMOPHILUS LYSATE
TRIETHOXYCAPRYLYLSILANE
WATER
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60934-005-01 1 TUBE in 1 BOX contains a TUBE
1 50 mL in 1 TUBE This package is contained within the BOX (60934-005-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 01/11/2017
Labeler — HydroPeptide LLC (006297465)

Revised: 12/2023 HydroPeptide 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.

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