Label: NATRIENCE BROAD SPECTRUM SPF 30- skin shield cream
- NDC Code(s): 84352-402-01
- Packager: Sisel International, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 28, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- OTC - Purpose
-
Indications and Usage
• Apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures: 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 value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
• For children under 6 months of age: Ask a doctor - Dosage and Administration
-
BOXED WARNING
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Boxed 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 use and ask a doctor if rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
- OTC - Keep out of reach of Children
-
Inactive Ingredients
Water (Aqua), Ethylhexyl Olivate, C9-12 Alkane, Hydroxyethyl Dimethicone Laurate, Propanediol, Calcium Sodium Borosilicate, Pentylene Glycol, Polymethylsilsesquioxane, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cocoglycerides, Jojoba Esters, Dimethicone, Betaine, Sucrose, Spirulina Maxima Extract, Fructooligosaccharides, Beta Vulgaris (Beet) Root Extract,
Hydrolyzed Rhodophyceae Extract, Helianthus Annuus (Sunflower) Seed Oil, Phaeodactylum Tricornutum Extract, Dipotassium Glycyrrhizate, Persea Gratissima (Avocado) Oil, Squalane, Caprylic/Capric Triglyceride, Tocopherol, Lecithin, Hydroxyacetophenone, Disteardimonium Hectorite, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Caprylyl Glycol, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Hydrogenated Vegetable Oil, Caprylhydroxamic Acid, Sodium Chloride, Sodium Citrate, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Fragrance (Natural). - Indications and Usage
- Warnings
-
Principal Display
DRUG FACTS
Active Ingredients Purpose
Zinc Oxide 20%........................ 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 use and ask a
doctor if rash occurs. • Keep out of
reach of children. If product is
swallowed, get medical help or contact a
Poison Control Center right away.
Directions
• Apply liberally 15 minutes before sun
exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen
if swimming or sweating
• Sun Protection Measures: 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
value of 15 or higher and other sun
protection measures including:
• Limit time in the sun, especially
from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants,
hats, and sunglasses
• For children under 6 months of age:
Ask a doctor
Inactive Ingredients:
Water (Aqua), Ethylhexyl Olivate, C9-12
Alkane, Hydroxyethyl Dimethicone
Laurate, Propanediol, Calcium Sodium
Borosilicate, Pentylene Glycol,
Polymethylsilsesquioxane, Butylene Glycol,
Butyloctyl Salicylate, C12-15 Alkyl
Benzoate, Cocoglycerides, Jojoba Esters,
Dimethicone, Betaine, Sucrose, Spirulina
Maxima Extract, Fructooligosaccharides,
Beta Vulgaris (Beet) Root Extract,
Hydrolyzed Rhodophyceae Extract,
Helianthus Annuus (Sunflower) Seed Oil,
Phaeodactylum Tricornutum Extract,
Dipotassium Glycyrrhizate, Persea
Gratissima (Avocado) Oil, Squalane,
Caprylic/Capric Triglyceride, Tocopherol,
Lecithin, Hydroxyacetophenone,
Disteardimonium Hectorite,
Polyhydroxystearic Acid,
Trihydroxystearin, Triethyl Citrate, Caprylyl
Glycol, Tetrasodium Glutamate Diacetate,
Sodium Dehydroacetate, Hydrogenated
Vegetable Oil, Caprylhydroxamic Acid,
Sodium Chloride, Sodium Citrate, Iron
Oxides (CI 77492), Iron Oxides (CI 77491),
Fragrance (Natural).
Other Information
Protect the product in this container from
excessive heat and direct sun. -
INGREDIENTS AND APPEARANCE
NATRIENCE BROAD SPECTRUM SPF 30
skin shield creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84352-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV) COCO-GLYCERIDES (UNII: ISE9I7DNUG) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TOCOPHEROL (UNII: R0ZB2556P8) C9-12 ALKANE (UNII: 7J5R5W72QM) PENTYLENE GLYCOL (UNII: 50C1307PZG) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) AVOCADO OIL (UNII: 6VNO72PFC1) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUNFLOWER OIL (UNII: 3W1JG795YI) PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) PROPANEDIOL (UNII: 5965N8W85T) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) SQUALANE (UNII: GW89575KF9) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) DIMETHICONE (UNII: 92RU3N3Y1O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BOROSILICATE GLASS (UNII: BOJ6T9AR90) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) BETAINE (UNII: 3SCV180C9W) SUCROSE (UNII: C151H8M554) SODIUM CHLORIDE (UNII: 451W47IQ8X) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) SPIRULINA MAXIMA (UNII: 9K7IG15M0Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84352-402-01 1 in 1 BOX 06/15/2024 1 20 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/15/2024 Labeler - Sisel International, LLC (794763198)