SOLAR DEFENSE TINTED- titanium dioxide, zinc oxide cream

Solar Defense Tinted by

Drug Labeling and Warnings

Solar Defense Tinted by is a Otc medication manufactured, distributed, or labeled by HydroPeptide LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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.
• 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 suncreen 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 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:

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	25 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BIOTIN (UNII: 6SO6U10H04)
BORON NITRIDE (UNII: 2U4T60A6YD)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRAL (UNII: T7EU0O9VPP)
CUCUMBER (UNII: YY7C30VXJT)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ACAI (UNII: 46AM2VJ0AW)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-100 STEARATE (UNII: YD01N1999R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60934-005-01	1 in 1 BOX	01/11/2017
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/11/2017

Labeler - HydroPeptide LLC (006297465)