NAPOLEON PERDIS AUTO PILOT BBB BROAD SPECTRUM SPF 30 MEDIUM-DARK- ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream

napoleon PERDIS AUTO PILOT BBB BROAD SPECTRUM SPF 30 MEDIUM-DARK by

Drug Labeling and Warnings

napoleon PERDIS AUTO PILOT BBB BROAD SPECTRUM SPF 30 MEDIUM-DARK by is a Otc medication manufactured, distributed, or labeled by Napoleon Perdis Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

napoleon PERDIS AUTO PILOT BBB CREAM BROAD SPECTRUM SPF 30 MEDIUM-DARK

Active ingredients

Ethylhexyl Methoxycinnamate 7.00%
Titanium Dioxide 6.14%
Zinc Oxide 6.90%

Purpose

Sunscreen

Uses

Helps to prevent sunburn. Higher SPF gives more sunburn protection.

Warnings

Skin cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn.

For external use only.
Use this product on the face.

When using this product:

Keep out of eyes. Rinse with water to remove.

Do not use

on damaged or broken skin.

Stop use and see 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 before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply as needed or after towel drying, swimming or sweating.

Other Information

Store this product from excessive heat and direct sun. High sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients:

WATER (AQUA), CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, SORBITOL, CETYL PEG/PPG-10/1 DIMETHICONE, MICA, ISONONYL ISONONANOATE, POLYGLYCERYL-4 ISOSTEARATE, TALC, DISTEARDIMONIUM HECTORITE, DIMETHICONE, SORBITAN SESQUIOLEATE, PPG-25-LAURETH-25, SODIUM CHLORIDE, POLYHYDROXYSTEARIC ACID, ALUMINA, ALUMINUM STEARATE, SILICA, ISOSTEARIC ACID, STEARIC ACID, ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE, SODIUM DEHYDROACETATE, TOCOPHERYL ACETATE, VACCINIUM MYRTILLUS SEED OIL, PERSEA GRATISSIMA (AVOCADO) OIL, CAMELLIA SINENSIS LEAF EXTRACT, GLYCOSAMINOGLYCANS, LYSINE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, ZINC CHLORIDE, HYDROGEN DIMETHICONE, DISODIUM EDTA, PHENOXYETHANOL, BENZYL ALCOHOL. MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Product Labels

INGREDIENTS AND APPEARANCE

NAPOLEON PERDIS AUTO PILOT BBB BROAD SPECTRUM SPF 30 MEDIUM-DARK 
ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51386-741
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	61.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	69 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SORBITOL (UNII: 506T60A25R)
MICA (UNII: V8A1AW0880)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TALC (UNII: 7SEV7J4R1U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PPG-25-LAURETH-25 (UNII: 2R54TS98QU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOSTEARIC ACID (UNII: X33R8U0062)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BILBERRY SEED OIL (UNII: KK0KHX972K)
AVOCADO OIL (UNII: 6VNO72PFC1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GAG (UNII: U5T7CTT5KM)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ZINC CHLORIDE (UNII: 86Q357L16B)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51386-741-00	1 in 1 CARTON	12/12/2013
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51386-741-01	1 mL in 1 PACKET; Type 0: Not a Combination Product	12/12/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/12/2013

Labeler - Napoleon Perdis Cosmetics, Inc (742094691)