PAMELA METAMORPHOSIS SUNSCREEN SPF 30- octinoxate, zinc oxide cream
Pamela Metamorphisis, Inc.

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Pamela Metamorphosis Sunscreen SPF 30

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:

Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71048-100-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2016	05/17/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/09/2016	05/17/2017

Labeler - Pamela Metamorphisis, Inc. (080403620)

Revised: 10/2023

Document Id: 0749bd93-cd61-1f61-e063-6394a90acf5a

Set id: 40e1d655-611c-2207-e054-00144ff88e88

Version: 2

Effective Time: 20231009

Pamela Metamorphisis, Inc.