PAMELA METAMORPHOSIS SUNSCREEN SPF 30- octinoxate, zinc oxide cream

Pamela Metamorphosis Sunscreen SPF 30 by

Drug Labeling and Warnings

Pamela Metamorphosis Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Pamela Metamorphisis, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octinoxate 7.50%

Zinc Oxide 5.00%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• 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 using and consult physician

if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions

• Apply liberally 15-minutes before sun exposure.
• Reapply:
• At least every two-hours.
• Immediately after swimming, sweating or towel drying. 
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection measures including:
• Limit time in the sun, especially between 10am and 2pm
• Wear long sleeve shirts, pants, hats and sunglasses.
• For children under 6-months, consult a physician.

Other Ingredients

Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Caprylic/Capric Triglyceride, Cocamidopropyl Betaine, Cyclopentasiloxane, Cyclotetrasiloxante, DEA Oleth-10 Phosphate, Hyaluronic Acid, Isohexadecane, Lactic Acid, Niacinamide, Octyldodecyl Neopantanoate, Phenoxyethanol, Polysorbate-80, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Popanediol.

Other Information:

• Protect this product from excessive heat and direct sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

PAMELA METAMORPHOSIS SUNSCREEN SPF 30 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71048-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIETHANOLAMINE OLETH-10 PHOSPHATE (UNII: 55HSP2Q1LM)
HYALURONIC ACID (UNII: S270N0TRQY)
ISOHEXADECANE (UNII: 918X1OUF1E)
LACTIC ACID (UNII: 33X04XA5AT)
NIACINAMIDE (UNII: 25X51I8RD4)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71048-100-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/09/2016

Labeler - Pamela Metamorphisis, Inc. (080403620)