OTC Medication Information: Alba Mineral Terra Tint SPF15 Garnet

ALBA MINERAL TERRA TINT SPF15 GARNET- zinc oxide cream
The Hain Celestial Group, 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.

Zinc Oxide 5.5%

Sunscreen

Cream. Apply liberally 15 minutes before sun exposure

For external use only. Do not use on damaged skin. When using this product keep out of eyes.

Helps prevent sunburn. If uses as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Beeswax, Caprylic/Capric Triglyceride, Mica, Titanium Dioxide, Oryza Sativa (Rice) Bran Wax, Mentha Pipperita (Peppermint) Oil (1), Olea Europaea (Olive) Fruit Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Stevia Rebaudiana Leaf/Stem Extract (1), Polyhydroxystearic Acid, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Manganese Violet.

(1)-Certified Organic Ingredients.

jar label
(click image for full-size original)

ALBA MINERAL TERRA TINT SPF15 GARNET
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2535
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
RICE BRAN
YELLOW WAX
MEDIUM-CHAIN TRIGLYCERIDES
MICA
TITANIUM DIOXIDE
PEPPERMINT OIL
OLIVE OIL
CALENDULA OFFICINALIS FLOWER
ECHINACEA PURPUREA
STEVIA REBAUDIUNA LEAF
POLYHYDROXYSTEARIC ACID (2300 MW)
POLYGLYCERYL-3 DIISOSTEARATE
.ALPHA.-TOCOPHEROL ACETATE
TRIETHOXYCAPRYLYLSILANE
FERRIC OXIDE RED
MANGANESE VIOLET
COCONUT OIL
SUNFLOWER OIL
CANDELILLA WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-2535-1 4.2 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/16/2013
Labeler — The Hain Celestial Group, Inc. (858894996)
Registrant — The Hain Celestial Group, Inc. (858894996)
Establishment
Name Address ID/FEI Operations
The Hain Celestial Group, Inc. 858894996 manufacture (61995-2535)

Revised: 10/2014 The Hain Celestial Group, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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