SUNSCREEN KARINA SKIN CARE MOIST- octinoxate, zinc oxide emulsion

Sunscreen Karina Skin Care Moist by

Drug Labeling and Warnings

Sunscreen Karina Skin Care Moist by is a Otc medication manufactured, distributed, or labeled by CA-Botana International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octinoxate 7.5%.............................................Sunscreen

Zinc Oxide 7.0%............................................. Sunscreen

Purpose

Sunscreen

Ask Doctor

Stop use and ask a doctor if rash occurs

Keep out of reach of children

Keep out of reach of children

Inactive Ingredients

Water (Aqua), Glycerine, Cetearyl isononanoate, Coco caprylate caprate, Prunus amygdalus dulcis (Sweet Almond) oil, Caprylic/Capric triglyceride, Cetyl alcohol, Propanediol, Aloe barbadensis leaf extract, Ascorbic acid, Ascorbyl palmitate, Olea europaea (Olive) leaf , Potassium sorbate, Rosmarinus officinalis (Rosemary) leaf, Tocopherol, Xanthan gum, Citric acid, Ethylhexylglycerin, Phenoxyethanol, Acrylates C10-30 Alkyl Acrylate Crosspolymer,Alpha Acetyl Tetrapeptide - 5, Butyloctyl Salicylate, Camellia sinensis (White tea) Leaf extract, Cetearyl Alcohol, Ceteareth-20, Chamomillla recutita (Matricaria)Flower extract, Emulsifying wax, Ethyl Ferulate, Euterpe Oleracea (Acai) Fruit extract, Ginkgo Biloba leaf extract, Juniperus communis (Juniper) Fruit, Malpighia punicifolia (Acerola) Fruit extract, Simmondsia chinensis (Jojoba) Seed oil, Sodium Phytate. Tocopheryl Acetate, Triethoxycaprylylsilane.

Safety information

Protect this product from excessive heat and direct sun

Dosage & Administration

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct 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. If product is swallowed get medical help or contact a poison Control Center right away.

Indications & Usage

Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN KARINA SKIN CARE MOIST 
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.919 g  in 141.7 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10.62 g  in 141.7 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
JUNIPERUS COMMUNIS STEM (UNII: HBU87MH6OY)
ROSEMARY (UNII: IJ67X351P9)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)
ACEROLA (UNII: XDD2WEC9L5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACETYL TETRAPEPTIDE-5 (UNII: Y1DFQ308G8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
WHITE TEA (UNII: O0M3396E09)
ALLANTOIN (UNII: 344S277G0Z)
OLIVE OIL (UNII: 6UYK2W1W1E)
ETHYL FERULATE (UNII: 5B8915UELW)
ACAI (UNII: 46AM2VJ0AW)
GINKGO BILOBA ROOT (UNII: 1XUK686051)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
WATER (UNII: 059QF0KO0R)
CETEARETH-22 (UNII: 28VZG1E234)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE) (UNII: PI80E777XB)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALMOND OIL (UNII: 66YXD4DKO9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)

Product Characteristics
Color	white (white yellowish)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-033-16	141.7 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/30/2021

Labeler - CA-Botana International (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-Botana International		106276728	manufacture(35192-033)