TINTED MOISTURIZER SPF 20- zinc oxide titanium dioxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)

Available from:

Kamins Dermatologics Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

This cream is enriched with moisturizing acai oil to help skin remain hydrated while adding a touch of color and glow to your skin. Uses ■ Helps prevent sunburn. ■ Higher SPF gives more sunburn protection. ■ Provides moderate protection against sunburn.

Authorization status:

OTC monograph final

Summary of Product characteristics

TINTED MOISTURIZER SPF 20 - ZINC OXIDE TITANIUM DIOXIDE CREAM
KAMINS DERMATOLOGICS INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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TINTED MOISTURIZER SPF 20 CONSUMER LABELING
Active ingredients:
Zinc Oxide 7.5%
Titanium Dioxide 4.4%
Purpose: Sunscreen
Keep out of reach of children.
This cream is enriched with moisturizing acai oil to help skin remain
hydrated while adding a touch of
color and glow to your skin.
Uses
■ Helps prevent sunburn.
■ Higher SPF gives more sunburn protection.
■ Provides moderate protection against sunburn.
Warnings
■ For external use only.
■ When using this product, keep out of eyes. If contact occurs,
rinse abundantly with water to remove.
■ Stop use and ask a doctor if rash or irritation develops and
lasts.
■ If swallowed, seek medical assistance or contact a Poison Control
Center immediately.
Directions
■ Apply in the morning and prior to sun exposure. Reapply as needed.
■ Children under 6 months of ask: ask a doctor.
Inactive ingredients: Aqua/Water/Eau, Caprylic/Capric Triglyceride,
Oleyl Oleate, Polyglyceryl-2
Dipolyhydroxystearate, Pentaerythrityl Tetraisostearate, Butylene
Glycol, Cyclopentasiloxane,
PEG/PPG-20/15 Dimethicone, Triethoxycaprylylsilane, Sodium Lauryl
Glucose Carboxylate, Lauryl
Glucoside, Glycerin, Xanthan gum, Magnesium Aluminum Silicate, Acai
Fruit Oil, Citric Acid, Isononyl
Isononanoate, Isopropyl Titanium Triisostearate, Synthetic Wax,
Caprylyl Glycol, Phenoxyethanol,
Sorbic Acid, Iron oxides (CI 77491, 77492).
B. KAMINS
TINTED MOISTURIZER SPF15
50mL / 1.7 fl.oz
NPN 80026968
image/jpg
TINTED MOISTURIZER SPF 20
zinc oxide titanium dioxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 3550 -158
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC